id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
14,240 | NDA 21-042/S-018
NDA 21-052/S-012
Page 3
VIOXX®
(rofecoxib tablets and oral suspension)
DESCRIPTION
VIOXX* (rofecoxib) is described chemically as 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2(5H)-furanone. It has
the following chemical structure:
O
O
S
O
O
H3C
Rofecoxib is a white to off-white to light yell... | custom-source | 2025-02-12T13:51:55.566186 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21042se8-018,21052se8-012_vioxx_lbl.pdf', 'application_number': 21042, 'submission_type': 'SUPPL ', 'submission_number': 18} |
14,241 | NDA 21-042/S-026
NDA 21-052/S-019
Page 1
1
VIOXX®
(rofecoxib tablets and oral suspension)
DESCRIPTION
VIOXX* (rofecoxib) is described chemically as 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2(5H)-furanone. It
has the following chemical structure:
O
O
S
O
O
H3C
Rofecoxib is a white to off-white to light ye... | custom-source | 2025-02-12T13:51:55.693177 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021052s026_021042s019lbl.pdf', 'application_number': 21042, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,244 | Carton Text
Plan B
(levonorgestrel) tablets, 0.75 mg
Introduction
Any woman who considers using Plan B should understand the benefits and risks. The
following information should help your understanding, but it is not meant to replace a
discussion between you and your health care provider.
What is Plan B?
Plan B is... | custom-source | 2025-02-12T13:51:55.881936 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21045lbl.pdf', 'application_number': 21045, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,242 |
VIOXX®
(rofecoxib tablets and oral suspension)
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious
cardiovascular thrombotic events, including m... | custom-source | 2025-02-12T13:51:56.015376 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf', 'application_number': 21042, 'submission_type': 'SUPPL ', 'submission_number': 33} |
14,243 |
... | custom-source | 2025-02-12T13:51:56.100033 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021044s013lbl.pdf', 'application_number': 21044, 'submission_type': 'SUPPL ', 'submission_number': 13} |
14,245 |
Celexa (citalopram hydrobromide) Tablets/Oral Solution
NDA 20-822/NDA 21-046
Proposed Labeling Text
Celexa®
(citalopram hydrobromide)
Tablets/Oral Solution
Rx Only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinki... | custom-source | 2025-02-12T13:51:56.181559 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf', 'application_number': 21046, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,248 | NDA 21-042/S-007, S-008, S-010, S-012, S-013, S-014
NDA 21-052/S-004, S-005, S-006, S-007, S-008, S-009
Page 4
VIOXX®
(rofecoxib tablets and oral suspension)
DESCRIPTION
VIOXX* (rofecoxib) is described chemically as 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2(5H)-furanone. It has the
following chemical structur... | custom-source | 2025-02-12T13:51:56.388092 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf', 'application_number': 21052, 'submission_type': 'SUPPL ', 'submission_number': 4} |
14,249 | NDA 21-042/S-007, S-008, S-010, S-012, S-013, S-014
NDA 21-052/S-004, S-005, S-006, S-007, S-008, S-009
Page 4
VIOXX®
(rofecoxib tablets and oral suspension)
DESCRIPTION
VIOXX* (rofecoxib) is described chemically as 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2(5H)-furanone. It has the
following chemical structur... | custom-source | 2025-02-12T13:51:56.547860 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf', 'application_number': 21052, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,246 |
Celexa®
(citalopram hydrobromide)
Tablets/Oral Solution
Rx Only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior
(suicidality) in children, adolesc... | custom-source | 2025-02-12T13:51:56.782523 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021046s020lbl.pdf', 'application_number': 21046, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,247 | Estradiol Transdermal System
Confidential
NDA 21-048
LABELING
ITEM 2
1
2.1 Draft Package Insert (Unannotated)
7-DAY ESTRADIOL TRANSDERMAL SYSTEM
PHYSICIANS LABELING
ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF
ENDOMETRIAL CARCINOMA IN POSTMENOPAUSAL WOMEN.
Close clinical surveillance of all women taking estroge... | custom-source | 2025-02-12T13:51:56.928364 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21048lbl.pdf', 'application_number': 21048, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,250 | NDA 21-042/S-007, S-008, S-010, S-012, S-013, S-014
NDA 21-052/S-004, S-005, S-006, S-007, S-008, S-009
Page 4
VIOXX®
(rofecoxib tablets and oral suspension)
DESCRIPTION
VIOXX* (rofecoxib) is described chemically as 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2(5H)-furanone. It has the
following chemical structur... | custom-source | 2025-02-12T13:51:56.987255 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf', 'application_number': 21052, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,251 | NDA 21-042/S-007, S-008, S-010, S-012, S-013, S-014
NDA 21-052/S-004, S-005, S-006, S-007, S-008, S-009
Page 4
VIOXX®
(rofecoxib tablets and oral suspension)
DESCRIPTION
VIOXX* (rofecoxib) is described chemically as 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2(5H)-furanone. It has the
following chemical structur... | custom-source | 2025-02-12T13:51:57.064625 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21042s7lbl.pdf', 'application_number': 21052, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,252 |
VIOXX®
(rofecoxib tablets and oral suspension)
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious
cardiovascular thrombotic events, including m... | custom-source | 2025-02-12T13:51:57.265392 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021042s033,021052s024lbl.pdf', 'application_number': 21052, 'submission_type': 'SUPPL ', 'submission_number': 24} |
14,253 | 1
PACKAGE INSERT
Targretin® (bexarotene) capsules, 75 mg
Rx only.
DESCRIPTION
Targretin® (bexarotene) is a member of a subclass of retinoids that selectively
activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity
distinct from that of retinoic acid receptors (RARs). Each soft gelatin ca... | custom-source | 2025-02-12T13:51:57.359180 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021055s002lbl.pdf', 'application_number': 21055, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,255 |
__________________
_________________
______________
______________
_____________
___________________
___________________
... | custom-source | 2025-02-12T13:51:57.505955 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021055s010lbl.pdf', 'application_number': 21055, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,256 |
Rx only.
DESCRIPTION
Targretin® (bexarotene) gel 1% contains bexarotene and is intended for topical
application only. Bexarotene is a member of a subclass of retinoids that selectively
activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity
distinct from that of ... | custom-source | 2025-02-12T13:51:57.575076 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021056s003lbl.pdf', 'application_number': 21056, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,254 |
Targretin® (bexarotene) capsules, 75 mg
Rx only.
Targretin capsules are a member of the retinoid class of drugs that is
associated with birth defects in humans. Targretin capsules also caused
birth defects when administered orally to pregnant rats. Targretin capsules
must not ... | custom-source | 2025-02-12T13:51:57.647490 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021055s008lbl.pdf', 'application_number': 21055, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,257 | Ganirelix PI
1
Antagon (ganirelix acetate) Injection
1
FOR SUBCUTANEOUS USE ONLY
2
3
DESCRIPTION
4
Antagon (ganirelix acetate) Injection is a synthetic decapeptide with high antagonistic
5
activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix
6
acetate is derived from native GnRH with ... | custom-source | 2025-02-12T13:51:57.858440 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21057lbl.pdf', 'application_number': 21057, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,260 | PRIALT (ziconotide intrathecal infusion)
For use only in the Medtronic SynchroMed® EL, SynchroMed® II Infusion System
and Cadd-Micro® ambulatory infusion pump
WARNING:
Severe psychiatric symptoms and neurological impairment may occur
during treatment with PRIALT. Patients with a pre-existing history of
psyc... | custom-source | 2025-02-12T13:51:58.018878 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021060s003lbl.pdf', 'application_number': 21060, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,259 |
... | custom-source | 2025-02-12T13:51:58.140044 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021057s010lbl.pdf', 'application_number': 21057, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,258 |
Logo
Manufactured for Organon USA Inc.
Roseland, NJ 07068
by Vetter Pharma-Fertigung GmbH & Co. KG
Ravensburg, Germany
and packaged by Organon (Ireland) Ltd.
Swords, Co. Dublin, Ireland
75293
12/07 10
FOR SUBCUTANEOUS USE ONLY
DESCRIPTION
Ganirelix Acetate Injection is a synthetic decapeptide wit... | custom-source | 2025-02-12T13:51:58.184739 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021057s007lbl.pdf', 'application_number': 21057, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,261 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to u... | custom-source | 2025-02-12T13:51:58.268024 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021060s006lbl.pdf', 'application_number': 21060, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,262 | custom-source | 2025-02-12T13:51:58.443065 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-064_Definity_prntlbl.pdf', 'application_number': 21064, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,264 | 515188-1007
October 2007
DEFINITYCI
Vial for (Perflutren Lipid Microsphere) Injectable Suspension
F or Intravenous Use
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30
minutes following DEFINITYCI administration.
. Assess all patients ... | custom-source | 2025-02-12T13:51:58.594220 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021064s007lbl.pdf', 'application_number': 21064, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,265 |
515188-0408
April 2008
DEFINITY®
Vial for (Perflutren Lipid Microsphere) Injectable Suspension
For Intravenous Use
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred during or following
perflutren-co... | custom-source | 2025-02-12T13:51:58.638383 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021064s009lbl.pdf', 'application_number': 21064, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,263 | 1
515188-0904
September 2004
DEFINITY®
Vial for (Perflutren Lipid Microsphere) Injectable Suspension
For Intravenous Use
DESCRIPTION
The DEFINITY® vial contains components that upon activation yield perflutren lipid
microspheres, a diagnostic drug that is intended to be used for contrast enhanc... | custom-source | 2025-02-12T13:51:58.665099 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021064s006lbl.pdf', 'application_number': 21064, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,266 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlight... | custom-source | 2025-02-12T13:51:58.857853 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021064s011lbl.pdf', 'application_number': 21064, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,270 | Page 1
ZADITOR™
ketotifen fumarate ophthalmic solution, 0.025%
DESCRIPTION
ZADITOR™ is a sterile ophthalmic solution containing ketotifen for topical administration to the eyes.
Ketotifen fumarate is a finely crystalline powder with an empirical formula of C23H23NO5S and a
molecular weight of 425.50.
N
S
O
CH3
H
COOH
H... | custom-source | 2025-02-12T13:51:58.878301 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21066lbl.pdf', 'application_number': 21066, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,269 | NDA 21-065/S-012
Page 3
femhrt
(norethindrone acetate/ethinyl estradiol tablets)
WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease
or dementia. (See WARNINGS, Cardiovascular disorders and Dementia.)
The Women’s Health Initiative (WHI) study reported inc... | custom-source | 2025-02-12T13:51:59.109201 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21065s012lbl.pdf', 'application_number': 21065, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,267 |
... | custom-source | 2025-02-12T13:51:59.201539 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021064s017lbl.pdf', 'application_number': 21064, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,271 |
______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:51:59.404587 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021067s003lbl.pdf', 'application_number': 21067, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,273 | 17128 Rocaltrol® Solution 11/20/98
1
(Roche Hexagon)
ROCALTROL®
brand of
calcitriol
CAPSULES and ORAL SOLUTION
DESCRIPTION: Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the
regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the
body. Rocaltrol is ... | custom-source | 2025-02-12T13:51:59.445891 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21068lbl.pdf', 'application_number': 21068, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,272 |
______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:51:59.648082 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021067s013lbl.pdf', 'application_number': 21067, 'submission_type': 'SUPPL ', 'submission_number': 13} |
14,274 | NDA 21-071/S-010
Page 3
PATIENT INFORMATION – Rx only
AVANDIA®
(ah-VAN-dee-a)
Rosiglitazone Maleate Tablets
Read the Patient Information that comes with AVANDIA before you start taking the medicine and
each time you get a refill. There may be new information. This information does not take the place of
talkin... | custom-source | 2025-02-12T13:51:59.669961 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s010lbl.pdf', 'application_number': 21071, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,275 | NDA 21-071/S-012
Page 3
AVANDIA®
(rosiglitazone maleate)
Tablets
DESCRIPTION
AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which acts primarily by
increasing insulin sensitivity. AVANDIA is used in the management of type 2 diabetes mellitus (also
known as non-insulin-dependent diabetes mel... | custom-source | 2025-02-12T13:51:59.801132 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s012lbl.pdf', 'application_number': 21071, 'submission_type': 'SUPPL ', 'submission_number': 12} |
14,276 | NDA 21-071/S-014
NDA 21-410/S-009
Page 3
AV:LX
PRESCRIBING INFORMATION
AVANDIA®
(rosiglitazone maleate)
Tablets
DESCRIPTION
AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which acts primarily by
increasing insulin sensitivity. AVANDIA is used in the management of type 2 diabetes mellitus (a... | custom-source | 2025-02-12T13:51:59.887619 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s014lbl.pdf', 'application_number': 21071, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,277 | NDA 21-071/S-015
Page 3
AV:LXX
PRESCRIBING INFORMATION
AVANDIA®
(rosiglitazone maleate)
Tablets
DESCRIPTION
AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which acts primarily by
increasing insulin sensitivity. AVANDIA is used in the management of type 2 diabetes mellitus (also
known as non... | custom-source | 2025-02-12T13:52:00.127590 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s015lbl.pdf', 'application_number': 21071, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,278 | NDA 21-071/S-019 and S-021
Page 3
AV:LXX
PRESCRIBING INFORMATION
AVANDIA®
(rosiglitazone maleate)
Tablets
DESCRIPTION
AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which acts primarily by
increasing insulin sensitivity. AVANDIA is used in the management of type 2 diabetes mellitus (also
kn... | custom-source | 2025-02-12T13:52:00.240652 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf', 'application_number': 21071, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,280 | NDA 21-071/S-027
Page 3
PRESCRIBING INFORMATION
AVANDIA®
(rosiglitazone maleate)
Tablets
WARNING: CONGESTIVE HEART FAILURE
● Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some
patients (see WARNINGS). After initiation of AVANDIA, and after dose increases, observe... | custom-source | 2025-02-12T13:52:00.608734 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s027lbl.pdf', 'application_number': 21071, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,279 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AVANDIA safely and effectively. See full prescribing information fo... | custom-source | 2025-02-12T13:52:00.609036 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s026lbl.pdf', 'application_number': 21071, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,281 |
... | custom-source | 2025-02-12T13:52:00.909561 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s034lbl.pdf', 'application_number': 21071, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,284 | ACTOS™ (Pioglitazone Hydrochloride) Tablets
NDA No. 21-073
Version: 21073LBL.DOC
Page 1
ACTOS™
(Pioglitazone Hydrochloride) Tablets
DESCRIPTION
ACTOS (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by
decreasing insulin resistance. ACTOS is used in the management of type 2 diabetes
mell... | custom-source | 2025-02-12T13:52:01.135706 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf', 'application_number': 21073, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,282 |
... | custom-source | 2025-02-12T13:52:01.211822 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021071s041lbl.pdf', 'application_number': 21071, 'submission_type': 'SUPPL ', 'submission_number': 41} |
14,283 |
... | custom-source | 2025-02-12T13:52:01.465205 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf', 'application_number': 21071, 'submission_type': 'SUPPL ', 'submission_number': 48} |
14,285 |
ACTOS®
(pioglitazone hydrochloride) Tablets
DESCRIPTION
ACTOS (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by decreasing insulin resistance.
ACTOS is used in the management of type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus
[NIDDM] or adult-onset... | custom-source | 2025-02-12T13:52:01.611029 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073slr071_actos_lbl.pdf', 'application_number': 21073, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,287 | NDA 21-073/S-024
Page 3
ACTOS®
(pioglitazone hydrochloride) Tablets
DESCRIPTION
ACTOS (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by
decreasing insulin resistance. ACTOS is used in the management of type 2 diabetes mellitus
(also known as non-insulin-dependent diabetes mel... | custom-source | 2025-02-12T13:52:01.762870 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s024lbl.pdf', 'application_number': 21073, 'submission_type': 'SUPPL ', 'submission_number': 24} |
14,286 | NDA 21-073/S-023
Page 3
ACTOS®
(pioglitazone hydrochloride) Tablets
DESCRIPTION
ACTOS (pioglitazone hydrochloride) is an oral antidiabetic agent that acts primarily by
decreasing insulin resistance. ACTOS is used in the management of type 2 diabetes mellitus
(also known as non-insulin-dependent diabetes mel... | custom-source | 2025-02-12T13:52:01.777426 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s023lbl.pdf', 'application_number': 21073, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,288 |
1
ACTOS®
(pioglitazone hydrochloride) Tablets
WARNING: CONGESTIVE HEART FAILURE
• Thiazolidinediones, including ACTOS, cause or exacerbate congestive heart
failure in some patients (see WARNINGS). After initiation of ACTOS, and after
dose increases, observe patients carefully for signs and symptoms of heart ... | custom-source | 2025-02-12T13:52:01.870551 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s030lbl.pdf', 'application_number': 21073, 'submission_type': 'SUPPL ', 'submission_number': 30} |
14,290 |
NDA 21-073/S-037
Page 5
MEDICATION GUIDE
ACTOS® (ak-TŌS)
(pioglitazone hydrochloride) tablets
Read this Medication Guide carefully before you start taking ACTOS and each time you get a
refill. There may be new information. This information does not take the place of talking w... | custom-source | 2025-02-12T13:52:02.049547 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf', 'application_number': 21073, 'submission_type': 'SUPPL ', 'submission_number': 37} |
14,293 | custom-source | 2025-02-12T13:52:02.529027 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-074_Avagard_Prntlbl.pdf', 'application_number': 21074, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,291 |
Page 1 of 43
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ACTOS
safely and effectively. See full prescribing information for ACTOS.
ACTOS (pioglitazone hydrochloride) tablet... | custom-source | 2025-02-12T13:52:02.603733 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf', 'application_number': 21073, 'submission_type': 'SUPPL ', 'submission_number': 43} |
14,289 |
ACTOS – V6-2 January 24, 2011
Page 1 of 43
ACT003 R15 + ACT003 R15/MG
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ACTOS
safely and effectively. See full prescribing inform... | custom-source | 2025-02-12T13:52:03.309798 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s035lbl.pdf', 'application_number': 21073, 'submission_type': 'SUPPL ', 'submission_number': 35} |
14,296 | custom-source | 2025-02-12T13:52:03.373072 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-076_Aleve_prntlbl.pdf', 'application_number': 21076, 'submission_type': 'ORIG ', 'submission_number': 1} | |
14,292 |
Page 1 of 43
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ACTOS
safely and effectively. See full prescribing information for ACTOS.
ACTOS (pioglitazone hydrochloride) tablet... | custom-source | 2025-02-12T13:52:03.385204 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf', 'application_number': 21073, 'submission_type': 'SUPPL ', 'submission_number': 44} |
14,297 | 1
PRESCRIBING INFORMATION
1
ADVAIR DISKUS® 100/50
2
(fluticasone propionate 100 mcg and salmeterol* 50 mcg inhalation powder)
3
4
ADVAIR DISKUS® 250/50
5
(fluticasone propionate 250 mcg and salmeterol* 50 mcg inhalation powder)
6
7
ADVAIR DISKUS® 500/50
8
(fluticasone propionate 500 mcg and salmeterol* 50 mcg inhalatio... | custom-source | 2025-02-12T13:52:03.517299 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077slr019_advair_lbl.pdf', 'application_number': 21077, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,300 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ADVAIR DISKUS safely and effectively. See full prescribing information
for ADVAIR DISKUS.
ADVAIR DISKUS® 100/50 (fluticasone propionate 100 mcg and
salmeterol 50 mcg inhalation powder)
ADVAIR DISKUS® 250/... | custom-source | 2025-02-12T13:52:03.974287 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf', 'application_number': 21077, 'submission_type': 'SUPPL ', 'submission_number': 29} |
14,298 | Effective Date: 03/31/2006
ADVAIR DISKUS® 100/50
(fluticasone propionate 100 mcg and salmeterol* 50 mcg inhalation
powder)
ADVAIR DISKUS® 250/50
(fluticasone propionate 250 mcg and salmeterol* 50 mcg inhalation
powder)
ADVAIR DISKUS® 500/50
(fluticasone propionate 500 mcg and salmeterol* 50 mcg inhalation
powd... | custom-source | 2025-02-12T13:52:04.147118 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021077s027lbl.pdf', 'application_number': 21077, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,301 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the inform... | custom-source | 2025-02-12T13:52:04.436979 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021077s042lbl.pdf', 'application_number': 21077, 'submission_type': 'SUPPL ', 'submission_number': 42} |
14,299 | 1
PRESCRIBING INFORMATION
1
ADVAIR DISKUS® 100/50
2
(fluticasone propionate 100 mcg and salmeterol* 50 mcg inhalation powder)
3
4
ADVAIR DISKUS® 250/50
5
(fluticasone propionate 250 mcg and salmeterol* 50 mcg inhalation powder)
6
7
ADVAIR DISKUS® 500/50
8
(fluticasone propionate 500 mcg and salmetero... | custom-source | 2025-02-12T13:52:04.481791 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s028lbl.pdf', 'application_number': 21077, 'submission_type': 'SUPPL ', 'submission_number': 28} |
14,302 |
... | custom-source | 2025-02-12T13:52:04.936284 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s051lbl.pdf', 'application_number': 21077, 'submission_type': 'SUPPL ', 'submission_number': 51} |
14,305 |
1
PRESCRIBING INFORMATION
1
MALARONE
2
(atovaquone and proguanil hydrochloride)
3
Tablets
4
MALARONE
5
(atovaquone and proguanil hydrochloride)
6
Pediatric Tablets
7
DESCRIPTION
8
MALARONE (atovaquone and proguanil hydrochloride) is a fixed-dose combination of the
9
antimalarial agents atovaquo... | custom-source | 2025-02-12T13:52:05.385179 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s002lbl.pdf', 'application_number': 21078, 'submission_type': 'SUPPL ', 'submission_number': 2} |
14,303 |
... | custom-source | 2025-02-12T13:52:05.666013 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s053lbl.pdf', 'application_number': 21077, 'submission_type': 'SUPPL ', 'submission_number': 53} |
14,306 | NDA 21-078/S-003
Page 5
Added text is double underlined and deleted text is in strikethrough.
PRESCRIBING INFORMATION
MALARONE™
(atovaquone and proguanil hydrochloride)
Tablets
MALARONE™
(atovaquone and proguanil hydrochloride)
Pediatric Tablets
DESCRIPTION
MALARONE (atovaquone and proguanil hydrochloride) is a fixed-... | custom-source | 2025-02-12T13:52:05.967138 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21078s3lbl.pdf', 'application_number': 21078, 'submission_type': 'SUPPL ', 'submission_number': 3} |
14,304 |
... | custom-source | 2025-02-12T13:52:06.069713 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021077s054lbl.pdf', 'application_number': 21077, 'submission_type': 'SUPPL ', 'submission_number': 54} |
14,307 | 1
PRESCRIBING INFORMATION
1
MALARONE
2
(atovaquone and proguanil hydrochloride)
3
Tablets
4
MALARONE
5
(atovaquone and proguanil hydrochloride)
6
Pediatric Tablets
7
DESCRIPTION
8
MALARONE (atovaquone and proguanil hydrochloride) is a fixed-dose combination of the
9
antimalarial agents atovaquone... | custom-source | 2025-02-12T13:52:06.155730 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s007lbl.pdf', 'application_number': 21078, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,308 | 1
PRESCRIBING INFORMATION
1
MALARONE®
2
(atovaquone and proguanil hydrochloride)
3
Tablets
4
MALARONE®
5
(atovaquone and proguanil hydrochloride)
6
Pediatric Tablets
7
DESCRIPTION
8
MALARONE (atovaquone and proguanil hydrochloride) is a fixed-dose combination of the
9
antimalarial agents atovaquone... | custom-source | 2025-02-12T13:52:06.314923 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021078s008,009lbl.pdf', 'application_number': 21078, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,309 |
NDA 21-078/S-014
Page 3
PRESCRIBING INFORMATION
MALARONE®
(atovaquone and proguanil hydrochloride)
Tablets
MALARONE®
(atovaquone and proguanil hydrochloride)
Pediatric Tablets
DESCRIPTION
MALARONE (atovaquone and proguanil hydrochloride) is a fixed-dose combination... | custom-source | 2025-02-12T13:52:06.476702 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021078s014lbl.pdf', 'application_number': 21078, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,312 | NDA 21-081/S-017
Page 1
Submission date: 11/15/04
1
Rev. XXXX
Rx Only
LANTUS®
(insulin glargine [rDNA origin] injection)
LANTUS® must NOT be diluted or mixed with any other insulin or solution.
DESCRIPTION
LANTUS® (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargin... | custom-source | 2025-02-12T13:52:06.822503 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21081s017lbl.pdf', 'application_number': 21081, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,310 |
--------------------------------------------------------------------------------------------------------------------------------------------------------------------... | custom-source | 2025-02-12T13:52:07.132621 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf', 'application_number': 21078, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,313 | Rev. March 2007
Rx Only
LANTUS®
(insulin glargine [rDNA origin] injection)
LANTUS® must NOT be diluted or mixed with any other insulin or solution.
DESCRIPTION
LANTUS® (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for
use as an injection. Insulin glargine is a r... | custom-source | 2025-02-12T13:52:07.253312 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021081s024lbl.pdf', 'application_number': 21081, 'submission_type': 'SUPPL ', 'submission_number': 24} |
14,315 | CI-7713
Rapamune
05/02/02
1
Rapamune®
(sirolimus)
Oral Solution and Tablets
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and
management of renal transplant patients should use Rapamune®... | custom-source | 2025-02-12T13:52:07.274361 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,316 | CI-7713
Rapamune
05/02/02
1
Rapamune®
(sirolimus)
Oral Solution and Tablets
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and
management of renal transplant patients should use Rapamune®... | custom-source | 2025-02-12T13:52:07.378806 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,317 | CI-7713
Rapamune
05/02/02
1
Rapamune®
(sirolimus)
Oral Solution and Tablets
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and
management of renal transplant patients should use Rapamune®... | custom-source | 2025-02-12T13:52:07.692473 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,318 | 1
Rapamune
(sirolimus)
Oral Solution and Tablets
only
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and
management of renal transplant patients should use Rapamune. Patients receiving ... | custom-source | 2025-02-12T13:52:08.193208 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr015,21110slr015_Rapamune_lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,320 |
1
Rapamune
(sirolimus)
Oral Solution and Tablets
only
This product’s label may have been revised after this insert was
used in production. For further product information and current
package insert, please visit www.wyeth.com or call our medical
communications department toll-free at 1-800-934-5556.
... | custom-source | 2025-02-12T13:52:08.196245 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,319 |
1
Rapamune
(sirolimus)
Oral Solution and Tablets
only
This product’s label may have been revised after this insert was
used in production. For further product information and current
package insert, please visit www.wyeth.com or call our medical
communications department toll-free at 1-800-934-5556.
... | custom-source | 2025-02-12T13:52:08.224212 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,322 | Rapamune
(sirolimus)
Oral Solution and Tablets
only
This product’s label may have been revised after this insert was
used in production. For further product information and current
package insert, please visit www.wyeth.com or call our medical
communications department toll-free at 1-800-934-5556.
WA... | custom-source | 2025-02-12T13:52:09.296414 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 25} |
14,323 | NDA 21-083/S-026
NDA 21-110/S-035
Page 3
Rapamune®
(sirolimus)
Oral Solution and Tablets
Rx only
This product's label may have been revised after this insert was used in production.
For further product information and current package insert, please visit
www.wyeth.com or call our medical communication... | custom-source | 2025-02-12T13:52:09.433919 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s026,021110s035lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 26} |
14,324 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See Full Prescribing Information for
Rapamune.
RAPAMUNE (sirolimus) ORAL SOLUTION AND TABLETS
Initial U.S. Approval: 1999
WARNING: IMMUNOSUPPRESSION, EXCESS MORTALITY IN D... | custom-source | 2025-02-12T13:52:09.511916 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s033,021110s043lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 33} |
14,321 | NDA 21-083/S-021, S-022
NDA 21-110/S-030, S-031
Page 4
Rapamune®
(sirolimus)
Oral Solution and Tablets
only
This product’s label may have been revised after this insert was
used in production. For further product information and current
package insert, please visit www.wyeth.com or call our medical
co... | custom-source | 2025-02-12T13:52:09.536758 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,325 | NDA 21-083/S-034
NDA 21-110/S-045
Page 4
Rapamune®
(sirolimus)
Oral Solution and Tablets
Rx only
WARNING:
Increased susceptibility to infection and the possible development of lymphoma may result from
immunosuppression. Only physicians experienced in immunosuppressive therapy and management of
renal tran... | custom-source | 2025-02-12T13:52:09.935942 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s034,021110s045lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 34} |
14,326 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See Full Prescribing Information for
Rapamune.
RAPAMUNE (sirolimus) ORAL SOLUTION AND TABLETS
Initial U.S. Approval: 1999
WARNING: IMMUNOSUPPRESSION, EXCESS MORTALITY IN D... | custom-source | 2025-02-12T13:52:10.199670 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s036s037,021110s047s048lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 37} |
14,328 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See full p... | custom-source | 2025-02-12T13:52:10.722336 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s040,021110s050lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 40} |
14,327 |
•
Increased Susceptibility to Infection and the
10/2007
Possible Development of Lymphoma (5.1)
1/2007
•
6/2007
Angioedema (5.5)
10/2007
•
Proteinuria (5.9)
•
Fluid Accumulation and Wound Healing (5.6)
Adverse Reactions ... | custom-source | 2025-02-12T13:52:10.931538 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s038,021110s049lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 38} |
14,329 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See full prescribing information for
Rapamune.
RAPAMUNE (sirolimus) ORAL SOLUTION AND TABLETS
Initial U.S. Approval: 1999
WARNING: IMMUNOSUPPRESSION, USE IS NOT
RECOMMENDED IN ... | custom-source | 2025-02-12T13:52:10.971913 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 42} |
14,330 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See full prescribing information for
Rapamune.
RAPAMUNE (sirolimus) ORAL SOLUTION AND TABLETS
Initial U.S. Approval: 1999
WARNING: IMMUNOSUPPRESSION, USE IS NOT
RECOMMENDED IN ... | custom-source | 2025-02-12T13:52:11.250511 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 43} |
14,331 |
NDA 21-083/S-046
NDA 21-110/S-056
Page 4
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights... | custom-source | 2025-02-12T13:52:11.479313 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 46} |
14,333 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See full prescribing information for
Rapamune.
RAPAMUNE (sirolimus) ORAL SOLUTION AND TABLETS
Initial U.S. Approval: 1999
WARNING: IMMUNOSUPPRESSION, USE IS NOT
RECOMMENDED IN ... | custom-source | 2025-02-12T13:52:11.647959 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s056,021110s074lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 56} |
14,334 |
... | custom-source | 2025-02-12T13:52:11.999931 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s058,021110s075lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 58} |
14,335 | AVELOX®
(moxifloxacin hydrochloride) Tablets
AVELOX® I.V.
(moxifloxacin hydrochloride
in sodium chloride injection)
2/25/03
DESCRIPTION
AVELOX® (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is
available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous
adm... | custom-source | 2025-02-12T13:52:12.266509 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,336 | AVELOX®
(moxifloxacin hydrochloride) Tablets
AVELOX® I.V.
(moxifloxacin hydrochloride in sodium chloride injection)
08753736, R.6
6/04
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent
infe... | custom-source | 2025-02-12T13:52:12.361478 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21085se1-022,21277se1-017_avelox_lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,332 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Rapamune safely and effectively. See full prescribing information ... | custom-source | 2025-02-12T13:52:12.408216 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021083s051,021110s065lbl.pdf', 'application_number': 21083, 'submission_type': 'SUPPL ', 'submission_number': 51} |
14,337 | 1
AVELOX®
(moxifloxacin hydrochloride) Tablets
AVELOX® I.V.
(moxifloxacin hydrochloride in sodium chloride injection)
08753736, R. 4
2/04
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
AVELOX and other antibacterial drugs, AVELOX should be us... | custom-source | 2025-02-12T13:52:12.569082 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277slr018,21085slr023_avelox_lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,338 | AVELOX®
(moxifloxacin hydrochloride) Tablets
AVELOX® I.V.
(moxifloxacin hydrochloride in sodium chloride injection)
08753736,R.5
4/04
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent
infections th... | custom-source | 2025-02-12T13:52:12.687301 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277s019,21085s024lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 24} |
14,340 | AVELOX®
(moxifloxacin hydrochloride) Tablets
AVELOX® I.V.
(moxifloxacin hydrochloride in sodium chloride injection)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent
infections that are prove... | custom-source | 2025-02-12T13:52:13.132099 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 29} |
14,342 |
NDA 21-085/S-042
NDA 21-277/S-036
Page 5
MEDICATION GUIDE
AVELOX® (AV-eh-locks)
(moxifloxacin hydrochloride)
Tablets
AVELOX® I.V. (AV-eh-locks)
(moxifloxacin hydrochloride in sodium chloride injecti... | custom-source | 2025-02-12T13:52:13.242938 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 42} |
14,341 | AVELOX®
(moxifloxacin hydrochloride) Tablets
AVELOX® I.V.
(moxifloxacin hydrochloride in sodium chloride injection)
XXXXXXX, R.X
02/08
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent
infe... | custom-source | 2025-02-12T13:52:13.400715 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s038,021277s031lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 38} |
14,339 | AVELOX®
(moxifloxacin hydrochloride) Tablets
AVELOX® I.V.
(moxifloxacin hydrochloride in sodium chloride injection)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
AVELOX® and other antibacterial drugs, AVELOX should be used only to treat or prevent
infections that are prove... | custom-source | 2025-02-12T13:52:13.658032 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,343 |
HIGHLIGHTS OF PRESCRIB... | custom-source | 2025-02-12T13:52:13.907882 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s044lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 44} |
14,344 |
1
AVELOX®
(moxifloxacin hydrochloride) Tablets
AVELOX® I.V.
(moxifloxacin hydrochloride in sodium chloride injection)
81532312, RX
9/09
WARNING:
Fluoroquinolones, including AVELOX®, are associated with an increased risk of
tendinitis and... | custom-source | 2025-02-12T13:52:14.064863 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s045,021277s039lbl.pdf', 'application_number': 21085, 'submission_type': 'SUPPL ', 'submission_number': 45} |
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