id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
13,416 | NDA 19-537/ S-053, S-054
NDA 20-780/S-017, S-018
Page 5
CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
08753744, R.4
4/04
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO® Tablets and CIPRO Oral
Suspension and other antibacterial drugs, C... | custom-source | 2025-02-12T13:50:02.544270 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,419 |
NDA 19-537/S-070, NDA 19-847/S-044, NDA 19-857/S-051
NDA 20-780/S-028, NDA 21-473/S-025
Page 6
MEDICATION GUIDE
CIPRO® (Sip-row)
(ciprofloxacin hydrochloride)
TABLETS
CIPRO® (Sip-row)
(ciprofloxacin)
ORAL SUSPENSION
CIPRO... | custom-source | 2025-02-12T13:50:02.711437 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 28} |
13,417 | CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
08935877, R.3
5/07
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 shoul... | custom-source | 2025-02-12T13:50:02.715692 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020780s24lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 24} |
13,422 |
structural formula
CIPRO® I.V.
(ciprofloxacin)
For Intravenous Infusion
07/11
WARNING:
Fluoroquinolones, including CIPRO® I.V., are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of
age, ... | custom-source | 2025-02-12T13:50:03.385773 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 38} |
13,418 |
CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
WARNING:
Fluoroquinolones, including CIPRO, are associated with an increased risk of tendinitis
and tendon rupture in all ages. This risk is further increased in older patients us... | custom-source | 2025-02-12T13:50:03.450321 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 26} |
13,420 | CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
11/11
WARNING:
Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of
age, in pati... | custom-source | 2025-02-12T13:50:03.703614 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 32} |
13,421 |
CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
WARNING:
Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older patients usually over 60 y... | custom-source | 2025-02-12T13:50:03.764246 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s078,020780s036lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 36} |
13,424 |
1
CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
07/13
WARNING:
Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of
age, in ... | custom-source | 2025-02-12T13:50:04.083532 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 40} |
13,423 |
CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
WARNING:
Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older patients usually o... | custom-source | 2025-02-12T13:50:04.259830 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s081,020780s039lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 39} |
13,426 | 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 | 2025-02-12T13:50:04.285911 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20781lbl.pdf', 'application_number': 20781, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,427 |
PRESCRIBING INFORMATION
1
ZOFRAN®
2
(ondansetron hydrochloride)
3
Tablets
4
5
ZOFRAN ODT®
6
(ondansetron)
7
Orally Disintegrating Tablets
8
9
ZOFRAN®
10
(ondansetron hydrochloride)
11
Oral Solution
12
DESCRIPTION
13
The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is on... | custom-source | 2025-02-12T13:50:04.570710 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf', 'application_number': 20781, 'submission_type': 'SUPPL ', 'submission_number': 7} |
13,425 |
... | custom-source | 2025-02-12T13:50:04.669824 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019537s083,020780s041lbl.pdf', 'application_number': 20780, 'submission_type': 'SUPPL ', 'submission_number': 41} |
13,428 |
PRESCRIBING INFORMATION
ZOFRAN®
(ondansetron hydrochloride)
Tablets
ZOFRAN ODT®
(ondansetron)
Orally Disintegrating Tablets
ZOFRAN®
(ondansetron hydrochloride)
Oral Solution
DESCRIPTION
The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron
hyd... | custom-source | 2025-02-12T13:50:04.739932 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf', 'application_number': 20781, 'submission_type': 'SUPPL ', 'submission_number': 13} |
13,429 |
1
2
PRESCRIBING INFORMATION
3
ZOFRAN®
4
(ondansetron hydrochloride)
5
Tablets
6
7
ZOFRAN ODT®
8
(ondansetron)
9
Orally Disintegrating Tablets
10
11 ... | custom-source | 2025-02-12T13:50:04.767364 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf', 'application_number': 20781, 'submission_type': 'SUPPL ', 'submission_number': 18} |
13,430 | FDA Approved labeling text for NDA 20-782
DN0780V1 CR22-05083
December 20, 2002
Page 1
(No. 3826 and, 7126)
NEW
DEPAKOTE® ER
DIVALPROEX SODIUM
EXTENDED-RELEASE TABLETS
Rx Only
BOX WARNING:
HEPATOTOXICITY:
HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID
AND ITS DERIVATIVES. EXPE... | custom-source | 2025-02-12T13:50:05.025855 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20782_depakote_lbl.pdf', 'application_number': 20782, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,431 | THALOMID (thalidomide) Capsules
TM
15 July 1998
Revised Package Insert
1
WARNING: SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS
1
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE
2
BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE
3
SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO
4
COULD BECOME... | custom-source | 2025-02-12T13:50:05.095443 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20785lbl.pdf', 'application_number': 20785, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,433 | 1
THALOMID® (thalidomide) Capsules 50 mg, 100 mg, & 200 mg
WARNING: SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS.
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE
BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD
NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO COULD BECOME
PREGNANT WHILE TAKING T... | custom-source | 2025-02-12T13:50:05.272381 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf', 'application_number': 20785, 'submission_type': 'SUPPL ', 'submission_number': 20} |
13,432 | THALOMID® Capsules
(thalidomide)
1
WARNING: SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS.
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE
BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD
NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO COULD BECOME
PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE D... | custom-source | 2025-02-12T13:50:05.300585 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf', 'application_number': 20785, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,434 | “DRAFT / PROPOSED PRESCRIBING INFORMATION”
THALOMID® (thalidomide) Capsules 50 mg, 100 mg, & 200mg
WARNING: SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS.
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH
DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE
USED BY WOMEN WHO ARE PREGNANT OR ... | custom-source | 2025-02-12T13:50:05.699853 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf', 'application_number': 20785, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,435 | “DRAFT / PROPOSED PRESCRIBING INFORMATION”
THALOMID® (thalidomide) Capsules 50 mg, 100 mg, & 200mg
WARNING: SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS.
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH
DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE
USED BY WOMEN WHO ARE PREGNANT OR ... | custom-source | 2025-02-12T13:50:05.852654 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf', 'application_number': 20785, 'submission_type': 'SUPPL ', 'submission_number': 23} |
13,436 |
Celgene Corporation
1
2
3
4
5
PROPOSED CHANGES TO APPROVED THALOMID® PACKAGE INSERT
Highlighted Version
THALOMID® (thalidomide) Capsules 50 mg, 100 mg, & 200mg
WARNING: SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS.
6
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE
7
SEVERE BIRTH DEFECTS OR ... | custom-source | 2025-02-12T13:50:06.271546 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430s000,020785s031lbl.pdf', 'application_number': 20785, 'submission_type': 'SUPPL ', 'submission_number': 31} |
13,438 | Page 1
Prescribing Information as of XXXX
ALLEGRA®
(fexofenadine hydrochloride)
Capsules and Tablets
DESCRIPTION
Fexofenadine hydrochloride, the active ingredient of ALLEGRA, is a histamine H1-receptor
antagonist with the chemical name (±)-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-
piperidinyl]-butyl]-α, α-dimethyl b... | custom-source | 2025-02-12T13:50:06.314747 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf', 'application_number': 20786, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,437 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information neede... | custom-source | 2025-02-12T13:50:06.327359 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf', 'application_number': 20785, 'submission_type': 'SUPPL ', 'submission_number': 40} |
13,439 |
S
tructural Formula
NDA 20786/S-026
Page 3
Rev. December 2009
ALLEGRA-D® 12 HOUR
(fexofenadine HCl 60 mg and
pseudoephedrine HCl 120 mg)
Extended-Release Tablets
DESCRIPTION
ALLEGRA-D® 12 HOUR (fexofenadine hydrochloride and pseudoephedrine hydrochloride)
Extended-Relea... | custom-source | 2025-02-12T13:50:06.444018 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020786s026lbl.pdf', 'application_number': 20786, 'submission_type': 'SUPPL ', 'submission_number': 26} |
13,440 |
®
Drug F
W
Do not use
if you ha
(certain
Parkinson’
kno
if you ha
The makers of Allegra® do not make store brand products.
The trade dress of this Allegra® package is subject to
trademark protection.
Dist. By: Chattem, I... | custom-source | 2025-02-12T13:50:07.381180 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s031lbl.pdf', 'application_number': 20786, 'submission_type': 'SUPPL ', 'submission_number': 31} |
13,442 | NDA 20-788/S-003
Page 3
PROPECIA
(Finasteride)
Tablets, 1 mg
DESCRIPTION
PROPECIA* (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II
5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT).
Finasteride is 4-azaandrost-1-... | custom-source | 2025-02-12T13:50:07.430146 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20788s3lbl.pdf', 'application_number': 20788, 'submission_type': 'SUPPL ', 'submission_number': 3} |
13,443 |
PROPECIA®
(finasteride)
Tablets, 1 mg
DESCRIPTION
PROPECIA* (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II
5α-reductase,
an
intracellular
enzyme
that
converts
the
androgen
testosteron... | custom-source | 2025-02-12T13:50:07.490470 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s017lbl.pdf', 'application_number': 20788, 'submission_type': 'SUPPL ', 'submission_number': 17} |
13,441 | 12 Hour
®
Allergy &
Congestion
®
Allergy &
Congestion
NON-DROWSY
Original Prescription Strength
Relief of:
®
Nasal Congestion
Sinus Congestion
& Pressure
Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Nose or Throat
Allergy &
Congestion
NDC 41167-4310-6
30 Tablets
fexofenadine HCl 60 mg/antihistamine
pseudoephedrine ... | custom-source | 2025-02-12T13:50:07.845255 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf', 'application_number': 20786, 'submission_type': 'SUPPL ', 'submission_number': 33} |
13,444 |
NDA 020788/S-022
Page 3
PROPECIA®
(finasteride)
Tablets, 1 mg
DESCRIPTION
PROPECIA® (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II
5α-reductase,
an
intracellular
enzyme
that
converts
the
... | custom-source | 2025-02-12T13:50:08.471246 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788Orig1s022lbl.pdf', 'application_number': 20788, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,446 | NDA 20-789; ZONEGRAN (zonisamide) Capsules 100mg
Page 1
FDA Approved Labeling Text dated 3/27/00
ZONEGRAN™ (zonisamide) capsules
Rx Only
DESCRIPTION
ZONEGRAN™ (zonisamide) is an antiseizure drug chemically classified as a
sulfonamide and unrelated to other antiseizure agents. The active ingredient is
zonisamide, 1,2-b... | custom-source | 2025-02-12T13:50:08.513199 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20789lbl.pdf', 'application_number': 20789, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,445 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PROPECIA safely and effectively. See full prescribing information
for PROPECIA.
PROPECIA
® (finasteride) tablets for oral use
Initial U.S. Approval: 1992
----------------------------INDICATIONS AND... | custom-source | 2025-02-12T13:50:08.535223 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020788s024lbl.pdf', 'application_number': 20788, 'submission_type': 'SUPPL ', 'submission_number': 24} |
13,447 | NDA 20-789/S-005; ZONEGRAN (zonisamide) Capsules 100mg
Page 1
FDA Approved Labeling Text dated 10/7/02
ZONEGRAN™ (zonisamide) capsules
Rx Only
DESCRIPTION
ZONEGRAN™ (zonisamide) is an antiseizure drug chemically classified as a
sulfonamide and unrelated to other antiseizure agents. The active ingredient is
zonisamide,... | custom-source | 2025-02-12T13:50:08.551333 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20789s5lbl.pdf', 'application_number': 20789, 'submission_type': 'SUPPL ', 'submission_number': 5} |
13,449 |
NDA 20789/S-024 /S-026
FDA Approved Labeling Text dated 3/29/10
ZONEGRAN® (zonisamide) capsules
Rx Only
DESCRIPTION
ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide
and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2
benzi... | custom-source | 2025-02-12T13:50:08.893854 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf', 'application_number': 20789, 'submission_type': 'SUPPL ', 'submission_number': 26} |
13,452 |
NDA 20-796/S-013 and S-012
Page 3 logo
T2000-10
89005303
COMTAN®
(entacapone) Tablets
Rx only
Prescribing Information
DESCRIPTION
Comtan® (entacapone) is available as tablets containing 200-mg entacapone.
Entacapone is an inhibitor of catechol-O-methyltransferase... | custom-source | 2025-02-12T13:50:09.189267 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf', 'application_number': 20796, 'submission_type': 'SUPPL ', 'submission_number': 13} |
13,451 |
NDA 20-796/S-013 and S-012
Page 3 logo
T2000-10
89005303
COMTAN®
(entacapone) Tablets
Rx only
Prescribing Information
DESCRIPTION
Comtan® (entacapone) is available as tablets containing 200-mg entacapone.
Entacapone is an inhibitor of catechol-O-methyltransferase... | custom-source | 2025-02-12T13:50:09.240497 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020796s012s013lbl.pdf', 'application_number': 20796, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,448 |
NDA 020789/S-012
FDA Approved Labeling Text dated 1/24/2012
Page 1
ZONEGRAN® (zonisamide) capsules
Rx Only
DESCRIPTION
ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide
and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2
... | custom-source | 2025-02-12T13:50:09.266150 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf', 'application_number': 20789, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,453 |
COMTAN®
(entacapone) Tablets
Rx only
Prescribing Information
DESCRIPTION
Comtan® (entacapone) is available as tablets containing 200 mg entacapone.
Entacapone is an inhibitor of catechol-O-methyltr... | custom-source | 2025-02-12T13:50:09.438976 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020796s016lbl.pdf', 'application_number': 20796, 'submission_type': 'SUPPL ', 'submission_number': 16} |
13,455 |
COMTAN®
(entacapone) Tablets
Rx only
Prescribing Information
DESCRIPTION
Comtan® (entacapone) is available as tablets containing 200 mg entacapone.
Entacapone is an inhibitor of catechol-O-methyltransferase... | custom-source | 2025-02-12T13:50:09.831022 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020796s026lbl.pdf', 'application_number': 20796, 'submission_type': 'SUPPL ', 'submission_number': 26} |
13,456 | NDA 20-799/S-006
Page 3
FLOXIN® Otic
(ofloxacin otic solution 0.3%)
DESCRIPTION:
FLOXIN® Otic (ofloxacin otic solution) 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for
otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated
carboxyquinolone with ... | custom-source | 2025-02-12T13:50:09.888822 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20799se2-006_floxin_lbl.pdf', 'application_number': 20799, 'submission_type': 'SUPPL ', 'submission_number': 6} |
13,454 |
COMTAN®
(entacapone) Tablets
Rx only
Prescribing Information
DESCRIPTION
Comtan® (entacapone) is available as tablets containing 200 mg entacapone.
Entacapone is an inhibitor of catechol-O-methyltransferase... | custom-source | 2025-02-12T13:50:09.894366 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020796s024lbl.pdf', 'application_number': 20796, 'submission_type': 'SUPPL ', 'submission_number': 24} |
13,457 | NDA 20-799/S-012
Page 3
FLOXIN® Otic
(ofloxacin otic solution 0.3%)
DESCRIPTION:
FLOXIN® Otic (ofloxacin otic solution) 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for
otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated
carboxyquinolone with ... | custom-source | 2025-02-12T13:50:09.996431 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20799slr012_floxin_lbl.pdf', 'application_number': 20799, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,459 |
__________________
_________________
______________
______________
_____________
___________________
___________________
... | custom-source | 2025-02-12T13:50:10.336428 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf', 'application_number': 20800, 'submission_type': 'SUPPL ', 'submission_number': 24} |
13,458 |
... | custom-source | 2025-02-12T13:50:10.339799 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf', 'application_number': 20800, 'submission_type': 'SUPPL ', 'submission_number': 20} |
13,461 | NEW!
Recloseable Package
Store at 25°C (77°F); Excursions permitted to 15-30°C (59-86°F).
Protect from moisture.
®Registered trademark of Merck & Co., Inc.
USES
• For Relief of heartburn, acid indigestion, and sour stomach;
• For Prevention of these symptoms brought on by consuming food and beverages.
ACT... | custom-source | 2025-02-12T13:50:10.739311 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20801fpl.pdf', 'application_number': 20801, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,463 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:50:11.035716 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20802slr009_excedrin_lbl.pdf', 'application_number': 20802, 'submission_type': 'SUPPL ', 'submission_number': 9} |
13,460 |
__________________
_________________
______________
______________
_____________
... | custom-source | 2025-02-12T13:50:11.062591 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf', 'application_number': 20800, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,464 | 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 | 2025-02-12T13:50:11.102141 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802s022.pdf', 'application_number': 20802, 'submission_type': 'SUPPL ', 'submission_number': 22} |
13,462 | 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 | 2025-02-12T13:50:11.140484 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20801S4lbl.pdf', 'application_number': 20801, 'submission_type': 'SUPPL ', 'submission_number': 4} |
13,469 |
Roche Logo
KLONOPIN® TABLETS
(clonazepam)
KLONOPIN® WAFERS
(clonazepam orally disintegrating tablets)
Rx only
DESCRIPTION
Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation
containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation ... | custom-source | 2025-02-12T13:50:11.387862 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf', 'application_number': 20813, 'submission_type': 'SUPPL ', 'submission_number': 5} |
13,466 | 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 | 2025-02-12T13:50:11.439756 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20803lbl.pdf', 'application_number': 20803, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,465 | 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 | 2025-02-12T13:50:11.501553 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802Orig1s024lbl.pdf', 'application_number': 20802, 'submission_type': 'SUPPL ', 'submission_number': 24} |
13,470 |
logo
KLONOPIN® TABLETS
(clonazepam)
KLONOPIN® WAFERS
(clonazepam orally disintegrating tablets)
Rx only
DESCRIPTION
Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation
containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation
containin... | custom-source | 2025-02-12T13:50:11.643165 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf', 'application_number': 20813, 'submission_type': 'SUPPL ', 'submission_number': 6} |
13,467 | custom-source | 2025-02-12T13:50:11.670573 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805-mr.pdf', 'application_number': 20805, 'submission_type': 'ORIG ', 'submission_number': 1} | |
13,472 |
... | custom-source | 2025-02-12T13:50:11.840806 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020816s019lbl.pdf', 'application_number': 20816, 'submission_type': 'SUPPL ', 'submission_number': 19} |
13,471 | custom-source | 2025-02-12T13:50:11.854965 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista_prntlbl_P1.pdf', 'application_number': 20815, 'submission_type': 'SUPPL ', 'submission_number': 3} | |
13,475 | Diovan HCT®
T2006-ProposedMAR
Diovan HCT®
valsartan and hydrochlorothiazide, USP
Combination Tablets
80 mg/12.5 mg
160 mg/12.5 mg
160 mg/25 mg
Rx only
Prescribing Information
USE IN PREGNANCY
When used in pregnancy during the second and third
trimesters, drugs that a... | custom-source | 2025-02-12T13:50:11.938416 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s032lbl.pdf', 'application_number': 20818, 'submission_type': 'SUPPL ', 'submission_number': 32} |
13,474 |
V3.doc
Diovan HCT®
valsartan and hydrochlorothiazide, USP
Combination Tablets
80 mg/12.5 mg
160 mg/12.5 mg
160 mg/25 mg
320 mg/12.5 mg
320 mg/25 mg
Rx only
Prescribing Information
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly
on the renin-angiot... | custom-source | 2025-02-12T13:50:12.043393 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020818s027lbl.pdf', 'application_number': 20818, 'submission_type': 'SUPPL ', 'submission_number': 27} |
13,476 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Diova... | custom-source | 2025-02-12T13:50:12.252434 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020818s043lbl.pdf', 'application_number': 20818, 'submission_type': 'SUPPL ', 'submission_number': 43} |
13,477 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to... | custom-source | 2025-02-12T13:50:12.384931 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818S051lbl.pdf', 'application_number': 20818, 'submission_type': 'SUPPL ', 'submission_number': 51} |
13,479 |
... | custom-source | 2025-02-12T13:50:12.580161 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s060lbl.pdf', 'application_number': 20818, 'submission_type': 'SUPPL ', 'submission_number': 60} |
13,478 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information... | custom-source | 2025-02-12T13:50:12.587170 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020818s053lbl.pdf', 'application_number': 20818, 'submission_type': 'SUPPL ', 'submission_number': 53} |
13,480 |
... | custom-source | 2025-02-12T13:50:12.823866 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020818s058s062lbl.pdf', 'application_number': 20818, 'submission_type': 'SUPPL ', 'submission_number': 62} |
13,483 |
DN1035V5 CR 25-003317
August 15, 2005
Page 1 of 13
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
(Nos. 4637, 1658)
NEW
Zemplar®
(paricalcitol) Injection
Fliptop Vial
Rx only
DESCRIPTION
Paricalcitol, USP, the active ingredient in Zemplar Injection, is a synthetically
man... | custom-source | 2025-02-12T13:50:12.893574 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020819s015lbl.pdf', 'application_number': 20819, 'submission_type': 'SUPPL ', 'submission_number': 15} |
13,484 | Celexa®
(citalopram hydrobromide)
Tablets/Oral Solution
Rx Only
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and
behavior (suicidality) in short-term studies in children and
adolescents with Major Depressive Disorder (MDD) and
other psychiatric disorders. Anyone cons... | custom-source | 2025-02-12T13:50:13.261788 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020822s29lbl.pdf', 'application_number': 20822, 'submission_type': 'SUPPL ', 'submission_number': 29} |
13,482 | Zemplar®
( paricalcitol injection)
F liptop Vial
Rx only
DESCRIPTION
Zemplar® (paricalcitol injection) is a synthetically manufactured vitamin D analog. It is available as
a sterile, clear, colorless, aqueous solution for intravenous injection. Each mL contains paricalcitol,
2 mcg; propylene glycol, 30% (v/v);... | custom-source | 2025-02-12T13:50:13.375852 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20819se5-014_zemplar_lbl.pdf', 'application_number': 20819, 'submission_type': 'SUPPL ', 'submission_number': 14} |
13,486 |
NDAs: 20-822 Celexa® (citalopram hydrobromide) Tablets
21-046 Celexa® (citalopram hydrobromide) Oral Solution
Page 1 of 32
Celexa®
(citalopram hydrobromide)
Tablets/Oral Solution
Rx Only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk comp... | custom-source | 2025-02-12T13:50:13.556848 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf', 'application_number': 20822, 'submission_type': 'SUPPL ', 'submission_number': 35} |
13,488 |
structural formula
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, ... | custom-source | 2025-02-12T13:50:13.719291 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf', 'application_number': 20822, 'submission_type': 'SUPPL ', 'submission_number': 40} |
13,485 | 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, adolescents, and young adults in short-term studies of major depressive
disorder (MDD) an... | custom-source | 2025-02-12T13:50:13.863400 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020822s034lbl.pdf', 'application_number': 20822, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,487 |
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 | 2025-02-12T13:50:14.043403 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf', 'application_number': 20822, 'submission_type': 'SUPPL ', 'submission_number': 37} |
13,489 |
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 | 2025-02-12T13:50:14.127660 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s043lbl.pdf', 'application_number': 20822, 'submission_type': 'SUPPL ', 'submission_number': 43} |
13,490 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Citalopram HBr occurs as a fine, white to off-white powder. Citalopram HBr is sparingly soluble
in wat... | custom-source | 2025-02-12T13:50:14.240582 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf', 'application_number': 20822, 'submission_type': 'SUPPL ', 'submission_number': 46} |
13,491 | EXELON
(rivastigmine tartrate)
Capsules
DESCRIPTION
EXELON
(rivastigmine tartrate) is a reversible cholinesterase inhibitor and is known
chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-
(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological
... | custom-source | 2025-02-12T13:50:14.479945 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20823lbl.pdf', 'application_number': 20823, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,495 | NDA 20-825 Approval Letter and Labeling
Page 4
ATTACHMENT 1
Ziprasidone
(Ziprasidone HCl)
DESCRIPTION
Ziprasidone is available as Ziprasidone Capsules (ziprasidone hydrochloride) for oral administration.
Ziprasidone is an antipsychotic agent that is chemically unrelated to phenothiazine or butyrophenone
antipsychotic a... | custom-source | 2025-02-12T13:50:14.673694 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20825lbl.pdf', 'application_number': 20825, 'submission_type': 'ORIG ', 'submission_number': 1} |
13,493 |
T2005-55
Exelon
®
(rivastigmine tartrate)
Capsules and Oral Solution
Rx only
Prescribing Information
DESCRIPTION
Exelon
® (rivastigmine tartrate) is a reversible cholinesterase inhibitor and is
known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl
carbamate hydr... | custom-source | 2025-02-12T13:50:14.750283 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020823s016,021025s008lbl.pdf', 'application_number': 20823, 'submission_type': 'SUPPL ', 'submission_number': 16} |
13,494 |
HIGHLIGHTS OF PRESCRIBING INFO... | custom-source | 2025-02-12T13:50:14.904565 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020823s009s027s028s029,021025s018s019s020lbl.pdf', 'application_number': 20823, 'submission_type': 'SUPPL ', 'submission_number': 29} |
13,496 |
1
69-5770-00-5.2
GEODON®
(ziprasidone HCl)
Capsules
GEODON®
(ziprasidone mesylate)
for Injection
FOR IM USE ONLY
DESCRIPTION
GEODON® is available as GEODON Capsules (ziprasidone hydrochloride) for oral administration and
as GEODON for Injection (ziprasidone mesylate) for intramuscular injection. Zi... | custom-source | 2025-02-12T13:50:15.016111 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020825s009lbl.pdf', 'application_number': 20825, 'submission_type': 'SUPPL ', 'submission_number': 9} |
13,497 |
1
GEODON®
(ziprasidone HCl)
Capsules
GEODON®
(ziprasidone mesylate)
for Injection
FOR IM USE ONLY
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at
an increased risk of death... | custom-source | 2025-02-12T13:50:15.329053 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s021,020919s012lbl.pdf', 'application_number': 20825, 'submission_type': 'SUPPL ', 'submission_number': 21} |
13,498 |
1
GEODON®
(ziprasidone HCl)
Capsules
GEODON®
(ziprasidone mesylate)
for Injection
FOR IM USE ONLY
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at
an increased risk of death... | custom-source | 2025-02-12T13:50:15.868489 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s026,020919s016lbl.pdf', 'application_number': 20825, 'submission_type': 'SUPPL ', 'submission_number': 26} |
13,500 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highl... | custom-source | 2025-02-12T13:50:15.894769 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf', 'application_number': 20825, 'submission_type': 'SUPPL ', 'submission_number': 38} |
13,499 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These ... | custom-source | 2025-02-12T13:50:15.951404 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s034lbl.pdf', 'application_number': 20825, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,501 |
HIGHLIGHTS OF P... | custom-source | 2025-02-12T13:50:16.160078 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf', 'application_number': 20825, 'submission_type': 'SUPPL ', 'submission_number': 47} |
13,503 |
1
Patient Information About FORTOVASE (FOR-toe-vase)
FORTOVASE
(saquinavir) Soft Gel Capsules
Generic Name: Saquinavir (sa-KWIN-a-veer)
ALERT: Find out about medicines that should NOT be taken with FORTOVASE.
Please also read the section MEDICINES YOU SHOULD NOT TAKE WITH
FORTOVASE.
Please read this produc... | custom-source | 2025-02-12T13:50:16.188831 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20828se2-015_fortovase_lbl.pdf', 'application_number': 20828, 'submission_type': 'SUPPL ', 'submission_number': 15} |
13,502 | custom-source | 2025-02-12T13:50:16.256170 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3_prntlbl.pdf', 'application_number': 20827, 'submission_type': 'ORIG ', 'submission_number': 1} | |
13,504 | NDA 21-785/S-001 NDA 21-785/S-002
NDA 20-828/S-019 NDA 20-828/S-020
NDA 20-628/S-022 NDA 20-628/S-023
Page 3
INVIRASE®
(saquinavir mesylate)
CAPSULES and TABLETS
Rx only
WARNING
INVIRASE® (saquinavir mesylate) capsules and tablets and FORTOVASE® (saquinavir) soft
gelatin capsules are not bioeq... | custom-source | 2025-02-12T13:50:16.491912 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf', 'application_number': 20828, 'submission_type': 'SUPPL ', 'submission_number': 19} |
13,507 |
9088823
1
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodium
is
des... | custom-source | 2025-02-12T13:50:16.583283 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 33} |
13,506 | 1
9088815
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodium
is
described
chemic... | custom-source | 2025-02-12T13:50:16.770919 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 17} |
13,509 |
XXXXXXX
1
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodium
is
des... | custom-source | 2025-02-12T13:50:16.920089 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 35} |
13,508 |
XXXXXXX
1
V09/14/2005
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodi... | custom-source | 2025-02-12T13:50:17.112708 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 34} |
13,510 |
9088826
1
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast
sodium
is
descr... | custom-source | 2025-02-12T13:50:17.414670 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 39} |
13,511 |
M
erck Logo
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits the c... | custom-source | 2025-02-12T13:50:17.560159 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 46} |
13,505 | 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 | 2025-02-12T13:50:17.667896 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20829s12lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 12} |
13,512 |
M
erck & Co., Inc. Logo and Address
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antago... | custom-source | 2025-02-12T13:50:17.676924 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 47} |
13,513 |
... | custom-source | 2025-02-12T13:50:17.851976 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s048lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 48} |
13,514 |
----------
... | custom-source | 2025-02-12T13:50:17.964696 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 49} |
13,515 |
M
erck & Co., Inc
SINGULAIR®
(MONTELUKAST SODIUM)
TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES
DESCRIPTION
Montelukast sodium, the active ingredient in SINGULAIR*, is a selective and orally active leukotriene
receptor antagonist that inhibits t... | custom-source | 2025-02-12T13:50:18.126689 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s051_020830s052_021409s028lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 51} |
13,516 | OME
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGULAIRIl
(montelukast sodium) tablets, chewable tablets, and oral
granules
Initial U.S. Approval: 1998
----------.--... | custom-source | 2025-02-12T13:50:18.302840 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s052lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 52} |
13,518 |
company logo
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGUL... | custom-source | 2025-02-12T13:50:18.522586 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 60} |
13,517 |
company logo
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SI... | custom-source | 2025-02-12T13:50:18.550246 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 57} |
13,519 | Reference ID: 3205312
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID: 3205312
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID... | custom-source | 2025-02-12T13:50:18.748439 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 61} |
13,520 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SINGULAIR safely and effectively. See full prescribing information
for SINGULAIR.
SINGULAIR
® (monte... | custom-source | 2025-02-12T13:50:18.835576 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s062lbl.pdf', 'application_number': 20829, 'submission_type': 'SUPPL ', 'submission_number': 62} |
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