id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
13,313 |
structural formula
TEVETEN®
(eprosartan mesylate)
400mg 600mg
Rx Only
PRESCRIBING INFORMATION
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-
angiotensin system can cause injury and even death to the developing fetus. When pregnanc... | custom-source | 2025-02-12T13:49:41.255372 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020738s026lbl.pdf', 'application_number': 20738, 'submission_type': 'SUPPL ', 'submission_number': 26} |
13,315 |
1
dn2594v1-teveten-redlined-2012-jul-26
TEVETEN®
(eprosartan mesylate)
400mg 600mg
Rx Only
PRESCRIBING INFORMATION
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue TEVETEN as soon as possible.
Drugs that act d... | custom-source | 2025-02-12T13:49:41.574508 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s028lbl.pdf', 'application_number': 20738, 'submission_type': 'SUPPL ', 'submission_number': 28} |
13,317 | custom-source | 2025-02-12T13:49:41.635866 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf', 'application_number': 20740, 'submission_type': 'SUPPL ', 'submission_number': 8} | |
13,318 | custom-source | 2025-02-12T13:49:41.660465 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf', 'application_number': 20740, 'submission_type': 'SUPPL ', 'submission_number': 13} | |
13,314 |
TEVETEN®
(eprosartan mesylate)
400mg 600mg
Rx Only
PRESCRIBING INFORMATION
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue TEVETEN as soon as possible.
Drugs that act directly on the renin-angiotensin syst... | custom-source | 2025-02-12T13:49:41.661977 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020738s027lbl.pdf', 'application_number': 20738, 'submission_type': 'SUPPL ', 'submission_number': 27} |
13,322 |
- 1 -
PRANDIN®
(repaglinide) Tablets (0.5, 1, and 2 mg)
Rx only
DESCRIPTION
PRANDIN® (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class used in
the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes
mellitus or NIDDM). Rep... | custom-source | 2025-02-12T13:49:41.943579 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20741s022lbl.pdf', 'application_number': 20741, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,320 | PRANDIN®
(repaglinide) Tablets (0.5, 1, and 2 mg)
Rx only
DESCRIPTION
PRANDIN® (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class
used in the management of type 2 diabetes mellitus (also known as non-insulin dependent
diabetes mellitus or NIDDM). Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(... | custom-source | 2025-02-12T13:49:42.089618 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s13lbl.pdf', 'application_number': 20741, 'submission_type': 'SUPPL ', 'submission_number': 13} |
13,321 | NDA 20-741/S-018
Page 3
PRANDIN®
(repaglinide) Tablets (0.5, 1, and 2 mg)
Rx only
DESCRIPTION
PRANDIN® (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class used
in the management of type 2 diabetes mellitus (also known as non-insulin dependent
diabetes mellitus or NIDDM). Repaglinid... | custom-source | 2025-02-12T13:49:42.159871 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20741slr018_prandin_lbl.pdf', 'application_number': 20741, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,319 | NDA 20-741/S-012
Page 3
(repaglinide) Tablets (0.5, 1, and 2 mg)
DESCRIPTION
PRANDIN® (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class used
in the management of type 2 diabetes mellitus (also known as non-insulin dependent
diabetes mellitus or NIDDM). Repaglinide, S(+)2-ethoxy-4(2... | custom-source | 2025-02-12T13:49:42.168583 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s12lbl.pdf', 'application_number': 20741, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,323 |
PRANDIN®
(repaglinide) Tablets (0.5, 1, and 2 mg)
Rx only
DESCRIPTION
PRANDIN® (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class used in
the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes
mellitus ... | custom-source | 2025-02-12T13:49:42.374827 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020741s034lbl.pdf', 'application_number': 20741, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,324 |
PRANDIN®
(repaglinide) Tablets (0.5, 1, and 2 mg)
Rx only
DESCRIPTION
PRANDIN® (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class used in
the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes
mellitu... | custom-source | 2025-02-12T13:49:42.558601 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020741s038lbl.pdf', 'application_number': 20741, 'submission_type': 'SUPPL ', 'submission_number': 38} |
13,326 | NDA 20-742/S-004
Page 3
AquaLase™ Solution
(balanced salt solution)
Sterile
DESCRIPTION: AquaLase™ Solution is a sterile balanced salt solution, each mL containing
sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate
(CaCl2·2H2O) 0.048%, magnesium chloride hexahydrate (Mg... | custom-source | 2025-02-12T13:49:42.615266 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20742slr003_aqualase_lbl.pdf', 'application_number': 20742, 'submission_type': 'SUPPL ', 'submission_number': 3} |
13,325 |
PRANDIN®
(repaglinide) Tablets (0.5, 1, and 2 mg)
Rx only
DESCRIPTION
PRANDIN® (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class used in
the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes
mellitu... | custom-source | 2025-02-12T13:49:42.623310 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020741s040lbl.pdf', 'application_number': 20741, 'submission_type': 'SUPPL ', 'submission_number': 40} |
13,327 | NDA 20-742/S-005 & S-006
Page 3
BSS
Sterile Irrigating Solution
(balanced salt solution)
DESCRIPTION: BSS Sterile Irrigating Solution is a sterile balanced salt solution, each mL
containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride
dihydrate (CaCl2·2H2O) 0.048%, magnes... | custom-source | 2025-02-12T13:49:42.689555 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf', 'application_number': 20742, 'submission_type': 'SUPPL ', 'submission_number': 5} |
13,328 | NDA 20-742/S-008
Page 3
BSS
Sterile Irrigating Solution
(balanced salt solution)
DESCRIPTION: BSS Sterile Irrigating Solution is a sterile balanced salt solution, each mL
containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride
dihydrate (CaCl2·2H2O) 0.048%, magnesium chlo... | custom-source | 2025-02-12T13:49:42.914765 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742s008lbl.pdf', 'application_number': 20742, 'submission_type': 'SUPPL ', 'submission_number': 8} |
13,329 | NDA 20743/S002
NORITATE
(metronidazole cream) Cream, 1%
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)
DESCRIPTION
NORITATE
(metronidazole cream) Cream, 1%, contains metronidazole, USP. Chemically,
metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The molecular formula for metronidazole
i... | custom-source | 2025-02-12T13:49:43.081805 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020743s002lbl.pdf', 'application_number': 20743, 'submission_type': 'SUPPL ', 'submission_number': 2} |
13,330 | 808179-02
PULMICORT TURBUHALER 200 mcg
(budesonide inhalation powder)
For Oral Inhalation Only.
Rx only
DESCRIPTION
Budesonide,
the
active
component
of
PULMICORT
TURBUHALER
200
mcg,
is
a
corticosteroid
designated
chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-
diene-3,20-dione
cyc... | custom-source | 2025-02-12T13:49:43.145699 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf', 'application_number': 20746, 'submission_type': 'SUPPL ', 'submission_number': 11} |
13,331 | NDA 20-746/S-021
Page 3
Effective Date: 07/17/2007
RHINOCORT AQUA
(budesonide)
Nasal Spray 32 mcg
DESCRIPTION
For Intranasal Use Only.
Budesonide, the active ingredient of RHINOCORT AQUA® Nasal Spray, is
an anti-inflammatory synthetic corticosteroid.
It is designated chemically as (RS)-11-beta, 16-alpha, 17... | custom-source | 2025-02-12T13:49:43.181886 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020746s021lbl.pdf', 'application_number': 20746, 'submission_type': 'SUPPL ', 'submission_number': 21} |
13,332 |
RHINOCORT AQUA®
(budesonide)
Nasal Spray 32 mcg
For Intranasal Use Only.
Rx only
DESCRIPTION
Budesonide, the active ingredient of RHINOCORT AQUA®
Nasal Spray, is an anti-inflammatory synthetic corticosteroid.
It is designated chemically as (RS)-11-beta, 16-... | custom-source | 2025-02-12T13:49:43.295665 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020746s024lbl.pdf', 'application_number': 20746, 'submission_type': 'SUPPL ', 'submission_number': 24} |
13,334 | The trade dress of this RHINOCORT package is subject
to trademark protection.
ALLERGY
SPRAY
How can we help?
1-800-343-7805
60 SPRAYS
0.169 fl oz (5 ml)
NON–DROWSY
RELIEF OF
• Nasal Congestion
• Runny Nose
• Itchy Nose
• Sneezing
Budesonide
(glucocorticoid)
Nasal spray, 32 mcg per spray
Nasal Allergy Symptom Reliev... | custom-source | 2025-02-12T13:49:43.939848 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020746Orig1s032.pdf', 'application_number': 20746, 'submission_type': 'SUPPL ', 'submission_number': 32} |
13,336 | NDA20-747/S-017
Page 2
ACTIQ®
CII
(oral transmucosal fentanyl citrate)
PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE IMPORTANT
WARNINGS IN THIS LABEL.
Actiq is indicated only for the management of breakthrough cancer pain in patients with
malignancies who ... | custom-source | 2025-02-12T13:49:44.077247 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20747s017lbl.pdf', 'application_number': 20747, 'submission_type': 'SUPPL ', 'submission_number': 17} |
13,333 |
______________________________________________________________________________
... | custom-source | 2025-02-12T13:49:44.211241 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020746s026lbl.pdf', 'application_number': 20746, 'submission_type': 'SUPPL ', 'submission_number': 26} |
13,335 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:49:44.278011 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20747lbl.pdf', 'application_number': 20747, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,337 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ACTIQ
safely and effectively. See full prescribing information for ACTIQ.
ACTIQ (fentanyl citrate) oral transmucosal lozenge, CII
Initial U.S. Approval: 1998
WARNINGS: IMPORTANCE OF PROPER PATIENT SELECT... | custom-source | 2025-02-12T13:49:44.899437 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020747s027lbl.pdf', 'application_number': 20747, 'submission_type': 'SUPPL ', 'submission_number': 27} |
13,339 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:49:45.030853 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020747s030lbl.pdf', 'application_number': 20747, 'submission_type': 'SUPPL ', 'submission_number': 30} |
13,340 |
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION
ERRORS, ABUSE POTENTIAL
See full prescribing information for complete boxed warning.
• Due to the risk of fatal respiratory depression, ACTIQ is
contraindicated in opioid non-tolerant patients (1) and in
management of acute or p... | custom-source | 2025-02-12T13:49:45.254065 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020747s034lbl.pdf', 'application_number': 20747, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,338 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:49:45.398879 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020747s029lbl.pdf', 'application_number': 20747, 'submission_type': 'SUPPL ', 'submission_number': 29} |
13,342 | NDA 20-753/S-003
Page 3
AROMASIN
exemestane tablets
DESCRIPTION
AROMASIN Tablets for oral administration contain 25 mg of exemestane, an irreversible,
steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-
diene-3,17-dione. Its molecular formula is C20H240... | custom-source | 2025-02-12T13:49:45.475885 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20753slr003_aromasin_lbl.pdf', 'application_number': 20753, 'submission_type': 'SUPPL ', 'submission_number': 3} |
13,343 | NDA 20-753/SLR-005
September 23, 2004
Approved labeling
1
AROMASIN
exemestane tablets
DESCRIPTION
AROMASIN Tablets for oral administration contain 25 mg of exemestane, an irreversible,
steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-
diene-3,17-dione. ... | custom-source | 2025-02-12T13:49:45.627967 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20753s005lbl.pdf', 'application_number': 20753, 'submission_type': 'SUPPL ', 'submission_number': 5} |
13,344 | AROMASIN® (exemestane tablets)
S-006 Approved Labeling
NDA 20-753/S-006
EBC Indication
October 4, 2005
1
AROMASIN®
exemestane tablets
DESCRIPTION
AROMASIN® Tablets for oral administration contain 25 mg of exemestane, an irreversible,
steroidal aromatase inactivator. Exemestane is chemically descr... | custom-source | 2025-02-12T13:49:45.768979 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020753s006lbl.pdf', 'application_number': 20753, 'submission_type': 'SUPPL ', 'submission_number': 6} |
13,346 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:49:46.021658 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf', 'application_number': 20753, 'submission_type': 'SUPPL ', 'submission_number': 11} |
13,345 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:49:46.148530 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf', 'application_number': 20753, 'submission_type': 'SUPPL ', 'submission_number': 9} |
13,347 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:49:46.211354 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020753s009s011s012lbl.pdf', 'application_number': 20753, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,348 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:49:46.342380 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020753s014lbl.pdf', 'application_number': 20753, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,349 |
... | custom-source | 2025-02-12T13:49:46.785866 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020753s015s016lbl.pdf', 'application_number': 20753, 'submission_type': 'SUPPL ', 'submission_number': 16} |
13,350 |
... | custom-source | 2025-02-12T13:49:46.915386 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020753s018lbl.pdf', 'application_number': 20753, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,351 | NDA 20-757/S-038
Page 3
AVAPRO®
Rx only
(irbesartan) Tablets
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the
renin-angiotensin system can cause injury and even death to the developing fetus. When
pregnancy is detected, AVAPRO should be disconti... | custom-source | 2025-02-12T13:49:46.920948 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020757s038lbl.pdf', 'application_number': 20757, 'submission_type': 'SUPPL ', 'submission_number': 38} |
13,352 |
AVAPRO®
Rx only
(irbesartan) Tablets
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act
directly on the renin-angiotensin system can cause injury and even death to the
developing fetus. When pregnancy is detected, AVAPRO should be discontinued as
soon as p... | custom-source | 2025-02-12T13:49:46.989795 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s056lbl.pdf', 'application_number': 20757, 'submission_type': 'SUPPL ', 'submission_number': 56} |
13,354 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AVALIDE® safely and effectively. See full prescribing information for
AVALIDE®.
AVALIDE® (irbesartan-hydrochlorothiazide) tablets
Initial U.S. Approval: 1997
WARNING: USE IN PREGNANCY
See full prescribing... | custom-source | 2025-02-12T13:49:47.246108 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020758s037lbl.pdf', 'application_number': 20758, 'submission_type': 'SUPPL ', 'submission_number': 37} |
13,356 |
NASONEX®
PRODUCT
1
2
3
4
5
6
7
8
9
10
11
12
(mometasone furoate monohydrate)
INFORMATION
Nasal Spray, 50 mcg*
FOR INTRANASAL USE ONLY
*calculated on the anhydrous basis
DESCRIPTION Mometasone furoate monohydrate, the active component of
NASONEX Nasal Spray, 50 mcg, is an anti-inflammatory co... | custom-source | 2025-02-12T13:49:47.359049 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20762s007lbl.pdf', 'application_number': 20762, 'submission_type': 'SUPPL ', 'submission_number': 7} |
13,353 | *Registered trademark
1
AVAPRO®
Rx only
(irbesartan) Tablets
DESCRIPTION
AVAPRO®* (irbesartan) is an angiotensin II receptor (AT1 subtype) antagonist.
Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-
tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
Its empirical... | custom-source | 2025-02-12T13:49:47.398151 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020757s058lbl.pdf', 'application_number': 20757, 'submission_type': 'SUPPL ', 'submission_number': 58} |
13,355 |
... | custom-source | 2025-02-12T13:49:47.483530 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s064lbl.pdf', 'application_number': 20758, 'submission_type': 'SUPPL ', 'submission_number': 64} |
13,357 | NASONEX NASAL SPRAY
PAGE 1
SECTION 2.
LABELING
PRODUCT
1
INFORMATION
2
NASONEX®
3
(mometasone furoate monohydrate)
4
Nasal Spray, 50 mcg*
5
FOR INTRANASAL USE ONLY
6
*calculated on the anhydrous basis
7
8
DESCRIPTION Mometasone furoate monohydrate, the active component of
9
NASONEX Nasal Spray, 50 mcg, is an anti-infl... | custom-source | 2025-02-12T13:49:47.596706 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20762s11lbl.pdf', 'application_number': 20762, 'submission_type': 'SUPPL ', 'submission_number': 11} |
13,358 | NASONEX
(mometasone furoate
monohydrate)
Nasal Spray, 50 mcg*
*calculated on the anhydrous basis
Shake the bottle well before each
use. Read complete instructions
carefully and use only as directed.
1. Remove the plastic cap (Figure 1).
2. The very first time the spray is
used, prime the pump by press-
ing downward on... | custom-source | 2025-02-12T13:49:47.735857 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20762slr021_nasonex_lbl.pdf', 'application_number': 20762, 'submission_type': 'SUPPL ', 'submission_number': 21} |
13,360 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
The... | custom-source | 2025-02-12T13:49:47.933694 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020762s044lbl.pdf', 'application_number': 20762, 'submission_type': 'SUPPL ', 'submission_number': 44} |
13,361 |
1
PRESCRIBING INFORMATION
2
AMERGE®
3
(naratriptan hydrochloride)
4
Tablets
5
DESCRIPTION
6
AMERGE Tablets contain naratriptan as the hydrochloride, which is a selective
7
5-hydroxytryptamine1 receptor subtype agonist. Naratriptan hydrochloride is chemically
8
designated as N-methyl-3-(1-methyl-4-... | custom-source | 2025-02-12T13:49:48.018721 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020763s008s009lbl.pdf', 'application_number': 20763, 'submission_type': 'SUPPL ', 'submission_number': 8} |
13,359 |
PAGE 1
PRODUCT
INFORMATION
NASONEX®
(mometasone furoate monohydrate)
Nasal Spray, 50 mcg*
FOR INTRANASAL USE ONLY
*calculated on the anhydrous basis
DESCRIPTION Mometasone furoate monohydrate, the active component of
NASONEX Nasal Spray, 50 mcg, is an anti-inflammatory corticosteroid having the
chemica... | custom-source | 2025-02-12T13:49:48.100484 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20762s023lbl.pdf', 'application_number': 20762, 'submission_type': 'SUPPL ', 'submission_number': 23} |
13,362 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:49:48.133004 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20764lbl.pdf', 'application_number': 20764, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,363 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:49:48.229525 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s03lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 1} |
13,365 | 1
PRESCRIBING INFORMATION
1
LAMICTAL®
2
(lamotrigine)
3
Tablets
4
5
LAMICTAL®
6
(lamotrigine)
7
Chewable Dispersible Tablets
8
9
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION
10
OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF
11
LAMICTAL. THE INCIDENCE OF THESE... | custom-source | 2025-02-12T13:49:48.464625 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 3} |
13,367 | 1
PRESCRIBING INFORMATION
1
LAMICTAL®
2
(lamotrigine)
3
Tablets
4
5
LAMICTAL®
6
(lamotrigine)
7
Chewable Dispersible Tablets
8
9
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION
10
OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF
11
LAMICTAL. THE INCIDENCE OF THESE... | custom-source | 2025-02-12T13:49:49.211456 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,366 | NDA 20-241/S-017 & NDA 20-764/S-011
FDA approved labeling text (6/20/03)
Page 1
1
PRESCRIBING INFORMATION
1
LAMICTAL®
2
(lamotrigine)
3
Tablets
4
5
LAMICTAL®
6
(lamotrigine)
7
Chewable Dispersible Tablets
8
9
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION
10
OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION ... | custom-source | 2025-02-12T13:49:49.358547 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20241se1-017,20764se1-011_lamictal_lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 11} |
13,364 | [17-JAN-2003]
LAMICTAL®
PRODUCT INFORMATION
1
(lamotrigine)
2
Tablets
3
4
LAMICTAL®
5
(lamotrigine)
6
Chewable Dispersible Tablets
7
8
9
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION
10
OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE
11
OF LAMICTAL. THE INCIDENCE OF THESE RASHES, WHICH HAVE
1... | custom-source | 2025-02-12T13:49:49.623071 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020241s008lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 2} |
13,368 | 1
PRESCRIBING INFORMATION
1
LAMICTAL®
2
(lamotrigine)
3
Tablets
4
5
LAMICTAL®
6
(lamotrigine)
7
Chewable Dispersible Tablets
8
9
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION
10
OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF
11
LAMICTAL. THE INCIDENCE OF THESE... | custom-source | 2025-02-12T13:49:49.925253 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 19} |
13,370 |
HIGHLIGHT... | custom-source | 2025-02-12T13:49:50.914117 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 29} |
13,372 |
... | custom-source | 2025-02-12T13:49:52.306174 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 33} |
13,369 |
... | custom-source | 2025-02-12T13:49:52.446780 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 28} |
13,373 |
... | custom-source | 2025-02-12T13:49:52.578935 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 38} |
13,374 |
NDA 020241/S-047
NDA 020764/S-040
NDA 02... | custom-source | 2025-02-12T13:49:52.904186 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,022251s010lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 40} |
13,377 | XENICAL 042399
h:\20766lbl.doc
XENICAL
(orlistat)
CAPSULES
DESCRIPTION: XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting
the absorption of dietary fats.
Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1-[[(2S, 3S)-3-hexyl-4-oxo-2-oxetanyl]
methyl]-dodecyl ester. Its ... | custom-source | 2025-02-12T13:49:53.560281 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf', 'application_number': 20766, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,378 | XENICAL 09/26/00
C:\dmautop\temp\LTRlblS007062101.doc
XENICAL
(orlistat)
CAPSULES
DESCRIPTION: XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by
inhibiting the absorption of dietary fats.
Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1-[[(2S, 3S)-3-hexyl-4-oxo-2-oxetanyl]
me... | custom-source | 2025-02-12T13:49:54.065289 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20766s7lbl.pdf', 'application_number': 20766, 'submission_type': 'SUPPL ', 'submission_number': 7} |
13,379 | 1
XENICAL
(orlistat)
CAPSULES
Rx only
DESCRIPTION
XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting
the absorption of dietary fats.
Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1-[[(2S, 3S)-3-hexyl-4-oxo-2-
oxetanyl] methyl]-dodecyl ester. Its empirical form... | custom-source | 2025-02-12T13:49:54.953634 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766s019lbl.pdf', 'application_number': 20766, 'submission_type': 'SUPPL ', 'submission_number': 19} |
13,380 | TO PHARMACIST: PLEASE PROVIDE THIS INFORMATION TO THE PATIENT.
Important Patient Information
Patient Information about XENICAL (orlistat) Capsules
XENICAL (zen′ i-cal)
Generic Name: orlistat
Rx only
Please read this information before you start taking XENICAL and each time
you renew your prescription. This ... | custom-source | 2025-02-12T13:49:54.993514 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766slr020_xenical_lbl.pdf', 'application_number': 20766, 'submission_type': 'SUPPL ', 'submission_number': 20} |
13,376 |
... | custom-source | 2025-02-12T13:49:55.062929 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 46} |
13,382 |
----------
... | custom-source | 2025-02-12T13:49:55.890456 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020766s026lbl.pdf', 'application_number': 20766, 'submission_type': 'SUPPL ', 'submission_number': 26} |
13,375 |
NDA 020241/S-049
NDA 020764/ S-0... | custom-source | 2025-02-12T13:49:56.207442 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,022251s012lbl.pdf', 'application_number': 20764, 'submission_type': 'SUPPL ', 'submission_number': 42} |
13,381 |
1
2
3
4
5
6
7
8
9
10
11
12
XENICAL®
(orlistat)
CAPSULES
Rx only
DESCRIPTION
XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting
the absorption of dietary fats.
Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1-[[(2S, 3S)-3-hexyl-4-oxo-2-
oxetanyl] methy... | custom-source | 2025-02-12T13:49:56.216644 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020766s022lbl.pdf', 'application_number': 20766, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,383 |
XENICAL®
(orlistat)
CAPSULES
Rx only
DESCRIPTION
XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting
the absorption of dietary fats.
Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1-[[(2S, 3S)-3-hexyl-4-oxo-2
oxetanyl] methyl]-dodecyl ester. Its empiric... | custom-source | 2025-02-12T13:49:56.528773 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s028lbl.pdf', 'application_number': 20766, 'submission_type': 'SUPPL ', 'submission_number': 28} |
13,384 |
... | custom-source | 2025-02-12T13:49:56.810057 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf', 'application_number': 20766, 'submission_type': 'SUPPL ', 'submission_number': 29} |
13,387 |
_______________________________________________________________________... | custom-source | 2025-02-12T13:49:56.922191 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf', 'application_number': 20768, 'submission_type': 'SUPPL ', 'submission_number': 21} |
13,386 | 1
SIC XXXXX-XX
ZOMIG
(zolmitriptan)
TABLETS
ZOMIG-ZMT
(zolmitriptan)
ORALLY DISINTEGRATING TABLETS
DESCRIPTION
ZOMIG®
(zolmitriptan)
Tablets
and
ZOMIG-ZMT
(zolmitriptan)
Orally
Disintegrating
Tablets
contain
zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D
(5-HT1B/1D) recept... | custom-source | 2025-02-12T13:49:57.027657 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20768s012lbl.pdf', 'application_number': 20768, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,385 |
... | custom-source | 2025-02-12T13:49:57.715631 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf', 'application_number': 20766, 'submission_type': 'SUPPL ', 'submission_number': 33} |
13,388 |
... | custom-source | 2025-02-12T13:49:57.808699 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020769s014lbl.pdf', 'application_number': 20769, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,389 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:49:57.851242 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20771lbl.pdf', 'application_number': 20771, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,390 | NDA 20-771/S-004
Page 3
DetrolTM
tolterodine tartrate tablets
DESCRIPTION
DETROL Tablets contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor
antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]-1-phenylpropyl]-4-
methylphenol [R-(R*,R*)]-2,3-dih... | custom-source | 2025-02-12T13:49:57.904564 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20771s4lbl.pdf', 'application_number': 20771, 'submission_type': 'SUPPL ', 'submission_number': 4} |
13,391 |
DESCRIPTION
DETROL Tablets contain tolterodine tartrate. The active moiety, tolterodine, is a
muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-
[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol
[R-(R*,R*)]-
2,3dihydroxybutanedioate (1:1) (salt). The empirical formula of ... | custom-source | 2025-02-12T13:49:58.211800 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020771s013lbl.pdf', 'application_number': 20771, 'submission_type': 'SUPPL ', 'submission_number': 13} |
13,394 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:49:58.224650 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20773lbl.pdf', 'application_number': 20773, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,393 |
Detrol®
tolterodine tartrate tablets
DESCRIPTION
DETROL Tablets contain tolterodine tartrate. The active moiety, tolterodine, is a
muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3
[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]
2,3dihydr... | custom-source | 2025-02-12T13:49:58.318217 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020771s028lbl.pdf', 'application_number': 20771, 'submission_type': 'SUPPL ', 'submission_number': 28} |
13,392 |
Detrol®
tolterodine tartrate tablets
DESCRIPTION
DETROL Tablets contain tolterodine tartrate. The active moiety, tolterodine, is a
muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3
[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol
[R-(R*,R*)]
2,3d... | custom-source | 2025-02-12T13:49:58.385613 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020771s019,021228s012lbl.pdf', 'application_number': 20771, 'submission_type': 'SUPPL ', 'submission_number': 19} |
13,395 | PerioChip
2.5 mg
®
(chlorhexidine gluconate)
DESCRIPTION
PerioChip (chlorhexidine gluconate) is a small, orange-brown, rectangular chip (rounded at one end) for
®
insertion into periodontal pockets. Each PerioChip weighs approximately 7.4 mg and contains 2.5 mg of
chlorhexidine gluconate in a biodegradable matrix of... | custom-source | 2025-02-12T13:49:58.557253 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20774lbl.pdf', 'application_number': 20774, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,397 |
PerioChip® 2.5mg
(Chlorhexidine gluconate)
DESCRIPTION
PerioChip® (chlorhexidine gluconate) is a small, orange-brown, rectangular chi... | custom-source | 2025-02-12T13:49:58.616179 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020774s012lbl.pdf', 'application_number': 20774, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,396 | (b) (4)
struc
tur
al
fo
rm
ula
logo
DESCRIPTION
Periochip® (chlorhexidine gluconate) is a small, orange-brown, rectangular chip
(rounded at one end) for insertion into periodontal pockets. Each periochip weighs
approximately 6.9 mg and contains 2.5 mg of chlorhexidine gluconate... | custom-source | 2025-02-12T13:49:58.769655 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020774Orig1s010lbl.pdf', 'application_number': 20774, 'submission_type': 'SUPPL ', 'submission_number': 10} |
13,398 | NDA 20776
Page 3
PHARMACIA
Daypro ALTA™
(oxaprozin potassium tablets)
DESCRIPTION
Daypro ALTA (oxaprozin potassium tablets) is a member of the propionic acid group of nonsteroidal anti-
inflammatory drugs (NSAIDs). Each blue, capsule-shaped tablet contains oxaprozin potassium (678mg
equivalent to 600... | custom-source | 2025-02-12T13:49:58.859900 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20776_Daypro_alta_lbl.pdf', 'application_number': 20776, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,399 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all t... | custom-source | 2025-02-12T13:49:59.136092 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020776s006lbl.pdf', 'application_number': 20776, 'submission_type': 'SUPPL ', 'submission_number': 6} |
13,400 | NDA 20-779/S-042
NDA 20-778/S-022
NDA 21-503/S-001
Page 3
69-6003-00-7.1
AGOURON PHARMACEUTICALS, INC.
La Jolla, CA 92037, USA
VIRACEPT
(nelfinavir mesylate)
TABLETS and ORAL POWDER
DESCRIPTION
VIRACEPT (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus (HIV)
protease. VIRACE... | custom-source | 2025-02-12T13:49:59.137739 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-022,20779se5-042,21503se5-001_viracept_lbl.pdf', 'application_number': 20778, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,402 | NDA 20-778/S-025
NDA 20-779/S-046
NDA 21-503/S-007
Page 4
VIRACEPT®
(nelfinavir mesylate)
TABLETS and ORAL POWDER
DESCRIPTION
VIRACEPT® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus
(HIV) protease. VIRACEPT Tablets are available for oral administration as a light blue,
cap... | custom-source | 2025-02-12T13:49:59.352124 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020778s025,020779s046,021503s007lbl.pdf', 'application_number': 20778, 'submission_type': 'SUPPL ', 'submission_number': 25} |
13,403 |
VIRACEPT®
(nelfinavir mesylate)
TABLETS and ORAL POWDER
DESCRIPTION
VIRACEPT® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency
virus (HIV) protease. VIRACEPT Tablets are available for oral administration as a light
blue, capsule-shaped tablet with a clear film... | custom-source | 2025-02-12T13:49:59.896604 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf', 'application_number': 20778, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,404 |
s
t
ruc
tu
ra
l
fo
rm
u
la
VIRACEPT®
(nelfinavir mesylate)
TABLETS and ORAL POWDER
DESCRIPTION
VIRACEPT® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency
virus (HIV) protease. VIRACEPT Tablets are available for oral administration as a light
blue, capsule-shaped ... | custom-source | 2025-02-12T13:50:00.438568 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf', 'application_number': 20778, 'submission_type': 'SUPPL ', 'submission_number': 35} |
13,405 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:50:00.447955 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020778s036,020779s057,021503s018lbl.pdf', 'application_number': 20778, 'submission_type': 'SUPPL ', 'submission_number': 36} |
13,401 | NDA 20-778/S-023
NDA 20-779/S-044
NDA 21-503/S-003
Page 3
69-6003-00-9
AGOURON PHARMACEUTICALS, INC.
La Jolla, CA 92037, USA
VIRACEPT
(nelfinavir mesylate)
TABLETS and ORAL POWDER
DESCRIPTION
VIRACEPT (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus (HIV)
protease. VIRACEPT... | custom-source | 2025-02-12T13:50:00.463463 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf', 'application_number': 20778, 'submission_type': 'SUPPL ', 'submission_number': 23} |
13,406 | NDA 20-779/S-042
NDA 20-778/S-022
NDA 21-503/S-001
Page 3
69-6003-00-7.1
AGOURON PHARMACEUTICALS, INC.
La Jolla, CA 92037, USA
VIRACEPT
(nelfinavir mesylate)
TABLETS and ORAL POWDER
DESCRIPTION
VIRACEPT (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus (HIV)
protease. VIRACE... | custom-source | 2025-02-12T13:50:00.730094 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778se5-022,20779se5-042,21503se5-001_viracept_lbl.pdf', 'application_number': 20779, 'submission_type': 'SUPPL ', 'submission_number': 42} |
13,407 | NDA 20-778/S-023
NDA 20-779/S-044
NDA 21-503/S-003
Page 3
69-6003-00-9
AGOURON PHARMACEUTICALS, INC.
La Jolla, CA 92037, USA
VIRACEPT
(nelfinavir mesylate)
TABLETS and ORAL POWDER
DESCRIPTION
VIRACEPT (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus (HIV)
protease. VIRACEPT... | custom-source | 2025-02-12T13:50:01.189759 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20778slr003,20779slr044,21503slr003_viracept_lbl.pdf', 'application_number': 20779, 'submission_type': 'SUPPL ', 'submission_number': 44} |
13,409 |
s
t
ruc
tu
ra
l
fo
rm
u
la
VIRACEPT®
(nelfinavir mesylate)
TABLETS and ORAL POWDER
DESCRIPTION
VIRACEPT® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency
virus (HIV) protease. VIRACEPT Tablets are available for oral administration as a light
blue, capsule-shaped ... | custom-source | 2025-02-12T13:50:01.398957 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020778s035,020779s056,021503s017lbl.pdf', 'application_number': 20779, 'submission_type': 'SUPPL ', 'submission_number': 56} |
13,408 |
VIRACEPT®
(nelfinavir mesylate)
TABLETS and ORAL POWDER
DESCRIPTION
VIRACEPT® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency
virus (HIV) protease. VIRACEPT Tablets are available for oral administration as a light
blue, capsule-shaped tablet with a clear film... | custom-source | 2025-02-12T13:50:01.417746 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020778s033s034,020779s054s055,021503s015s016lbl.pdf', 'application_number': 20779, 'submission_type': 'SUPPL ', 'submission_number': 54} |
13,410 |
... | custom-source | 2025-02-12T13:50:01.620092 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020778s038,020779s059,021503s021lbl.pdf', 'application_number': 20779, 'submission_type': 'SUPPL ', 'submission_number': 59} |
13,411 | 1
CIPRO® (ciprofloxacin hydrochloride) TABLETS
1
CIPRO® (ciprofloxacin*) ORAL SUSPENSION
2
PZXXXXXX
3/02
3
DESCRIPTION
4
CIPRO® (ciprofloxacin hydrochloride) Tablets and CIPRO (ciprofloxacin) Oral Suspension are
5
synthetic broad spectrum antimicrobial agents for oral administration. Ciprofloxacin
6
hydrochloride, US... | custom-source | 2025-02-12T13:50:01.786526 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19537s41lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 11} |
13,412 | NDA 19-537/S-048, S-050, S-051
NDA 20-780/S-012, S-014, S-015
Page 7
CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
08753744, R.2 1/04
To reduce the development of drug-resistant bacteria an... | custom-source | 2025-02-12T13:50:02.034537 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,413 | NDA 19-537/S-048, S-050, S-051
NDA 20-780/S-012, S-014, S-015
Page 7
CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
08753744, R.2 1/04
To reduce the development of drug-resistant bacteria an... | custom-source | 2025-02-12T13:50:02.056708 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,414 | NDA 19-537/S-048, S-050, S-051
NDA 20-780/S-012, S-014, S-015
Page 7
CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
08753744, R.2 1/04
To reduce the development of drug-resistant bacteria an... | custom-source | 2025-02-12T13:50:02.128609 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 15} |
13,415 | CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
Anthrax draft
1/6/05
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO®
Tablets and CIPRO Oral Suspension and other antibacterial drugs, CIPRO Tablets and CIPRO Oral
Suspension sho... | custom-source | 2025-02-12T13:50:02.322313 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 16} |
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