id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
11,731 |
... | custom-source | 2025-02-12T13:45:58.880014 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf', 'application_number': 19810, 'submission_type': 'SUPPL ', 'submission_number': 93} |
11,732 |
... | custom-source | 2025-02-12T13:45:59.003548 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf', 'application_number': 19810, 'submission_type': 'SUPPL ', 'submission_number': 96} |
11,733 |
_____________________________________________________________________________________________________________________... | custom-source | 2025-02-12T13:45:59.212403 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf', 'application_number': 19810, 'submission_type': 'SUPPL ', 'submission_number': 97} |
11,736 | 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 | 2025-02-12T13:45:59.457817 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814s12lbl.pdf', 'application_number': 19814, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,735 |
... | custom-source | 2025-02-12T13:45:59.522908 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019813s060lblcorrection.pdf', 'application_number': 19813, 'submission_type': 'SUPPL ', 'submission_number': 60} |
11,734 |
... | custom-source | 2025-02-12T13:45:59.719385 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf', 'application_number': 19810, 'submission_type': 'SUPPL ', 'submission_number': 101} |
11,737 | NDA 18-754/S-027, 19-816/S-010
Page 3
®
Orudis®
[o´´roo´dis]
(ketoprofen)
Capsules
Oruvail®
[or´ü vāl]
(ketoprofen)
Extended-Release Capsules
] only
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction (MI), and stroke, which can b... | custom-source | 2025-02-12T13:45:59.779940 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018754s027,019816s010lbl.pdf', 'application_number': 19816, 'submission_type': 'SUPPL ', 'submission_number': 10} |
11,738 |
ADAGEN®
(pegademase bovine) Injection
DESCRIPTION
AD... | custom-source | 2025-02-12T13:45:59.881449 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf', 'application_number': 19818, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,740 | NDA 19-821/S-002
NDA 19-821/S-006
Page 3
________________________________________________________________
Professional Package Insert
SORIATANE®
(acitretin)
CAPSULES
CAUSES BIRTH
DEFECTS
DO NOT
GET PREGNANT
CONTRAINDICATIONS AND WARNINGS: Soriatane must not be used by females who are pre... | custom-source | 2025-02-12T13:46:00.136576 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf', 'application_number': 19821, 'submission_type': 'SUPPL ', 'submission_number': 2} |
11,741 | NDA 19-821/S-014
NDA 19-821/S-015
Page 3
<Stiefel® logo>
SORIATANE®
(acitretin)
CAPSULES
<CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT logo>
Rx only
CONTRAINDICATIONS AND WARNINGS: Soriatane must not be used by females who are pregnant, or who
intend to become pregnant during therapy or at any time fo... | custom-source | 2025-02-12T13:46:00.296003 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf', 'application_number': 19821, 'submission_type': 'SUPPL ', 'submission_number': 15} |
11,742 | NDA 019821/S-022
Page 3
SORIATANE®
(acitretin)
Capsules Do not get pregnant graphic
CONTRAINDICTIONS AND WARNINGS: Pregnancy
SORIATANE must not be used by females who are pregnant, or who intend to become
pregnant during therapy or at any time for at least 3 years following discontinuation of
therapy. SORIATANE ... | custom-source | 2025-02-12T13:46:00.504910 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s022lbl.pdf', 'application_number': 19821, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,743 | NDA 019821/S-024
Page 3
SORIATANE®
(acitretin)
Capsules Do Not get pregnant
CONTRAINDICTIONS AND WARNINGS: Pregnancy
SORIATANE must not be used by females who are pregnant, or who intend to become
pregnant during therapy or at any time for at least 3 years following discontinuation of
therapy. SORIATANE also mus... | custom-source | 2025-02-12T13:46:00.572888 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s024lbl.pdf', 'application_number': 19821, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,744 |
SORIATANE®
(acitretin)
Capsules avoid pregnancy logo
CONTRAINDICATIONS AND WARNINGS: Pregnancy
SORIATANE must not be used by females who are pregnant, or who intend to become
pregnant du... | custom-source | 2025-02-12T13:46:01.055684 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019821s027lbl.pdf', 'application_number': 19821, 'submission_type': 'SUPPL ', 'submission_number': 27} |
11,745 | Reference ID: 3241011
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID: 3241011
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 | 2025-02-12T13:46:01.076618 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019822Orig1s007lbl.pdf', 'application_number': 19822, 'submission_type': 'SUPPL ', 'submission_number': 7} |
11,746 | 2
LOPROX® Lotion
(ciclopirox)
0.77%
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
Rx Only
DESCRIPTION
LOPROX® Lotion (ciclopirox) 0.77% is for topical use.
Each gram of LOPROX® Lotion contains 7.70 mg of ciclopirox (as
ciclopirox olamine) in a water miscible lotion base consisting of Purified
Water USP, Cocamide DEA,... | custom-source | 2025-02-12T13:46:01.113074 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr009_loprox_lbl.pdf', 'application_number': 19824, 'submission_type': 'SUPPL ', 'submission_number': 9} |
11,748 | Page 2
9179714
630002-14
TABLETS
PLENDIL
(felodipine)
EXTENDED-RELEASE TABLETS
DESCRIPTION
PLENDIL* (felodipine) is a calcium antagonist (calcium channel blocker). Felodipine is a
dihydropyridine derivative that is chem-ically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-
dihydro-2,6-dimethyl... | custom-source | 2025-02-12T13:46:01.151028 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19834s17lbl.pdf', 'application_number': 19834, 'submission_type': 'SUPPL ', 'submission_number': 17} |
11,749 | NDA 19-834/S-022
Page 3
9179716
630002-16
PLENDIL
(felodipine)
EXTENDED-RELEASE TABLETS
DESCRIPTION
PLENDIL (felodipine) is a calcium antagonist (calcium channel blocker). Felodipine is a
dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-
dihydro-2,6-d... | custom-source | 2025-02-12T13:46:01.343926 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19834slr022_plendil_lbl.pdf', 'application_number': 19834, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,751 | custom-source | 2025-02-12T13:46:01.474909 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19-839S026_Zoloft_prntlbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 26} | |
11,752 | 1
ENCLOSURE
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
DESCRIPTION
ZOLOFT® (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral
administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following
chemical name: (1S-cis)-4-(3,4-dichlorophe... | custom-source | 2025-02-12T13:46:01.686599 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19839se5-se5-044,20990se5-010_zoloft_lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 44} |
11,750 | 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 | 2025-02-12T13:46:01.731515 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019835s032lbl.pdf', 'application_number': 19835, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,753 | 1
[FDA Approved Labeling for Zoloft® for the Treatment of Social Anxiety Disorder
Attachment to FDA Approval Letter for NDA 19-839/S-045]
69-4721-00-4.2
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
DESCRIPTION
ZOLOFT® (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for o... | custom-source | 2025-02-12T13:46:01.945878 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020990s011lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,756 |
1
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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 di... | custom-source | 2025-02-12T13:46:02.325903 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019839s058s060,020990s024s026lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 60} |
11,754 |
1
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
DESCRIPTION
ZOLOFT® (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral
administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following
chemical name: (1S-cis)-4-(3... | custom-source | 2025-02-12T13:46:02.562277 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19839s047,050,20990s013,017lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 50} |
11,757 |
1
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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... | custom-source | 2025-02-12T13:46:03.126528 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019839s068,020990s031lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 68} |
11,755 |
1
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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 di... | custom-source | 2025-02-12T13:46:03.161060 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019839s053S054lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 53} |
11,758 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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
depr... | custom-source | 2025-02-12T13:46:03.536800 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019839s070,020990s032lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 70} |
11,759 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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 (... | custom-source | 2025-02-12T13:46:04.293234 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 75} |
11,760 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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 (... | custom-source | 2025-02-12T13:46:04.372261 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019839s072s075s076,020990s033s036s037lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 76} |
11,761 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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... | custom-source | 2025-02-12T13:46:04.550438 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 80} |
11,762 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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... | custom-source | 2025-02-12T13:46:04.685449 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s080s083,020990s039s041lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 83} |
11,764 | Indium In 111 Chloride Sterile
Solution
Rx Only.
Diagnostic - For use only in radiolabeling
OncoScint® CR/OV (Satumomab Pendetide) and
ProstaScint™(Capromab Pendetide).
Radioimmunotherapy - For use only in radiolabel-
ing Zevalin™(Ibritumomab Tiuxetan).
FOR SINGLE USE ONLY
DESCRIPTION:
Indium In 111 Chloride Sterile So... | custom-source | 2025-02-12T13:46:04.911314 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111mal021902LB.pdf', 'application_number': 19841, 'submission_type': 'SUPPL ', 'submission_number': 3} |
11,765 | NDA 19-842/S-019
Page 3
MOTRIN® (ibuprofen) Suspension 100 mg/5 mL
Cardiovascular Risk
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke,
which can be fatal. This risk may increase with duration of use. Patients with cardiovascular ... | custom-source | 2025-02-12T13:46:05.194713 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019842s019lbl.pdf', 'application_number': 19842, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,766 | NDA 19-845/S-017
Page 3
Betoptic S
(betaxolol HCL)
0.25% as base
DESCRIPTION: BETOPTIC S Ophthalmic Suspension 0.25% contains betaxolol
hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile resin
suspension formulation. Betaxolol hydrochloride is a white, crystalline... | custom-source | 2025-02-12T13:46:05.235660 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19845slr017_betopic_lblo.pdf', 'application_number': 19845, 'submission_type': 'SUPPL ', 'submission_number': 17} |
11,763 |
ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
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
depr... | custom-source | 2025-02-12T13:46:05.347929 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019839s084,020990s043lbl.pdf', 'application_number': 19839, 'submission_type': 'SUPPL ', 'submission_number': 84} |
11,767 |
____________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:46:05.355771 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019845s021lbl.pdf', 'application_number': 19845, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,769 | CIPRO® I.V.
(ciprofloxacin)
For Intravenous Infusion
08724752, R.6
4/04
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO® I.V.
and other antibacterial drugs, CIPRO I.V. should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by ba... | custom-source | 2025-02-12T13:46:06.035117 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 29} |
11,770 | 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 | 2025-02-12T13:46:06.645409 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 30} |
11,768 | CIPRO®
1
(ciprofloxacin hydrochloride)
2
TABLETS
3
CIPRO®
4
(ciprofloxacin*)
5
ORAL SUSPENSION
6
7
XXXXXXXX 3/25/04
8
9
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPR... | custom-source | 2025-02-12T13:46:06.691629 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 27} |
11,771 | CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
XXXXXX
11/05
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 should be use... | custom-source | 2025-02-12T13:46:07.003890 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,773 |
2/11
CIPRO® I.V.
(ciprofloxacin)
For Intravenous Infusion
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, in patients taki... | custom-source | 2025-02-12T13:46:07.766539 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 47} |
11,772 |
CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
81532304, R.1
02/09
WARNING:
Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis
and tendon rupture in all ages. This risk is further increased in ol... | custom-source | 2025-02-12T13:46:07.989920 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 43} |
11,775 |
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 | 2025-02-12T13:46:08.082496 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 52} |
11,774 |
7/11
CIPRO® I.V.
(ciprofloxacin)
For Intravenous Infusion
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, in patients taki... | custom-source | 2025-02-12T13:46:08.084638 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 50} |
11,776 |
... | custom-source | 2025-02-12T13:46:08.431524 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s055,019857s063lbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 55} |
11,778 |
T2002-06
89008505
Lotensin
®
benazepril hydrochloride
Tablets
Rx only
Prescribing Information
Use in Pregnancy
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause
injury and even death to the developing fetus. When pregnancy is detected, Lotensin should
be dis... | custom-source | 2025-02-12T13:46:08.505785 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/019851s028lbl.pdf', 'application_number': 19851, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,779 |
company logo
Lotensin®
(benazepril hydrochloride)
Tablets
Rx only
Prescribing Information
USE IN PREGNANCY
When used in pregnancy, ACE inhibitors can cause injury and even death to the
developing fetus. When pregnancy is detected, Lotensin should be discontinued as soon as
possible. See WARNINGS, Fet... | custom-source | 2025-02-12T13:46:08.568817 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019851s040lbl.pdf', 'application_number': 19851, 'submission_type': 'SUPPL ', 'submission_number': 40} |
11,781 |
78732XX
NDA 19-853 Cuprimine/S-012 & 014
Page 1
CAPSULES
CUPRIMINE®
(PENICILLAMINE)
Physicians planning to use penicillamine should thoroughly familiarize themselves with its toxicity, special
dosage considerations, and therapeutic benefits. Penicillamine should never be used casually. Each patient
sh... | custom-source | 2025-02-12T13:46:08.961696 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf', 'application_number': 19853, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,782 |
78732XX
NDA 19-853 Cuprimine/S-012 & 014
Page 1
CAPSULES
CUPRIMINE®
(PENICILLAMINE)
Physicians planning to use penicillamine should thoroughly familiarize themselves with its toxicity, special
dosage considerations, and therapeutic benefits. Penicillamine should never be used casually. Each patient
sh... | custom-source | 2025-02-12T13:46:09.029003 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf', 'application_number': 19853, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,777 |
... | custom-source | 2025-02-12T13:46:09.037411 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s056,019857s064lbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,780 |
... | custom-source | 2025-02-12T13:46:09.089475 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf', 'application_number': 19851, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,786 | CIPRO®
1
(ciprofloxacin hydrochloride)
2
TABLETS
3
CIPRO®
4
(ciprofloxacin*)
5
ORAL SUSPENSION
6
7
XXXXXXXX 3/25/04
8
9
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPR... | custom-source | 2025-02-12T13:46:09.504383 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,783 |
NDA 19-856/S-025
Page 3
®
SINEMET CR
(CARBIDOPA-LEVODOPA)
SUSTAINED-RELEASE TABLETS
DESCRIPTION
SINEMET* CR (Carbidopa-Levodopa) is a sustained-release combination of carbidopa and levodopa
for the treatment of Parkinson's disease and syndrome.
Carbidopa, an inhibitor of aromatic ami... | custom-source | 2025-02-12T13:46:09.587881 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019856s025lbl.pdf', 'application_number': 19856, 'submission_type': 'SUPPL ', 'submission_number': 25} |
11,784 |
SINEMET
® CR
(carbidopa levodopa)
Sustained-Release Tablets
DESCRIPTION
SINEMET® CR (carbidopa levodopa) is a sustai... | custom-source | 2025-02-12T13:46:09.623771 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019856s016s024s028lbl.pdf', 'application_number': 19856, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,785 | 1
CIPRO® (ciprofloxacin hydrochloride) TABLETS
1
CIPRO® (ciprofloxacin) 5% and 10% ORAL SUSPENSION
2
3
PZXXXXXX
8/29/00
4
5
DESCRIPTION
6
CIPRO® (ciprofloxacin hydrochloride) Tablets and CIPRO® (ciprofloxacin) Oral
7
Suspension are synthetic broad spectrum antimicrobial agents for oral
8
administration. Ciprofloxacin ... | custom-source | 2025-02-12T13:46:09.774892 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 27} |
11,787 | CIPRO® I.V.
(ciprofloxacin)
For Intravenous Infusion
08724752, R.6
4/04
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO® I.V.
and other antibacterial drugs, CIPRO I.V. should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by ba... | custom-source | 2025-02-12T13:46:09.942556 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,788 | CIPRO® I.V.
(ciprofloxacin)
For Intravenous Infusion
08724752, R.6
4/04
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO® I.V.
and other antibacterial drugs, CIPRO I.V. should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by ba... | custom-source | 2025-02-12T13:46:10.002425 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,789 | CIPRO® I.V.
(ciprofloxacin)
For Intravenous Infusion
08938299, R.2
5/07
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO® I.V.
and other antibacterial drugs, CIPRO I.V. should be used only to treat or prevent infections that are
proven or strongly suspected to be c... | custom-source | 2025-02-12T13:46:10.177929 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019857s46lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 46} |
11,791 |
2/11
CIPRO® I.V.
(ciprofloxacin)
For Intravenous Infusion
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, in patients taki... | custom-source | 2025-02-12T13:46:10.646202 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,790 |
CIPRO®
(ciprofloxacin hydrochloride)
TABLETS
CIPRO®
(ciprofloxacin*)
ORAL SUSPENSION
81532304, R.1
02/09
WARNING:
Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis
and tendon rupture in all ages. This risk is further increased in ol... | custom-source | 2025-02-12T13:46:10.932012 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 50} |
11,792 |
7/11
CIPRO® I.V.
(ciprofloxacin)
For Intravenous Infusion
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, in patients taki... | custom-source | 2025-02-12T13:46:10.953841 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 57} |
11,793 |
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 | 2025-02-12T13:46:10.987233 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 59} |
11,794 |
1
CIPRO® IV
(ciprofloxacin)
For Intravenous Infusion
07/13
WARNING:
Fluoroquinolones, including CIPRO® IV, 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 patients taking corticosteroid d... | custom-source | 2025-02-12T13:46:11.241377 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019857s062lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 62} |
11,796 | 1
CIPRO® (ciprofloxacin hydrochloride) TABLETS
1
CIPRO® (ciprofloxacin) 5% and 10% ORAL SUSPENSION
2
3
PZXXXXXX
8/29/00
4
5
DESCRIPTION
6
CIPRO® (ciprofloxacin hydrochloride) Tablets and CIPRO® (ciprofloxacin) Oral
7
Suspension are synthetic broad spectrum antimicrobial agents for oral
8
administration. Ciprofloxacin ... | custom-source | 2025-02-12T13:46:11.407258 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf', 'application_number': 19858, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,795 |
... | custom-source | 2025-02-12T13:46:11.739198 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019857s065lbl.pdf', 'application_number': 19857, 'submission_type': 'SUPPL ', 'submission_number': 65} |
11,797 | High Purity lndium
Chloride In-11 1
Sterile Solution
Diagnostic - For Use in Radiolabeling
OncoScint@, ProstaScint’“, and Zevalin”
(see package insert for indications)
For single dose, single use only
ProductCodes:INS.lPA/INS.lPAF
This label may not be the latest approved by FDA.
For current labeling informat... | custom-source | 2025-02-12T13:46:11.762241 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111med021902LB.pdf', 'application_number': 19862, 'submission_type': 'SUPPL ', 'submission_number': 6} |
11,799 |
... | custom-source | 2025-02-12T13:46:11.971495 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019865s021lbl.pdf', 'application_number': 19865, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,798 | custom-source | 2025-02-12T13:46:12.035096 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_prntlbl.pdf', 'application_number': 19865, 'submission_type': 'SUPPL ', 'submission_number': 10} | |
11,801 | Directions
■ do not take more than directed
(see overdose warning)
Drug Facts (cont nued)
Other information
■ store at 20-25°C (68-77°F) Avoid excessive heat
40°C (104°F)
■ do not use if carton is opened or neck wrap or
foil inner seal imprinted with “Safety Seal®”
is broken
■ see end panel for lot num... | custom-source | 2025-02-12T13:46:12.574496 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019872s031Lbl.pdf', 'application_number': 19872, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,800 | 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
| custom-source | 2025-02-12T13:46:12.584456 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19872slr012_tylenol_lbl.pdf', 'application_number': 19872, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,802 | 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 | 2025-02-12T13:46:12.676040 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019872Orig1s039lbl.pdf', 'application_number': 19872, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,804 | 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 | 2025-02-12T13:46:12.832608 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s041lbl.pdf', 'application_number': 19872, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,806 |
... | custom-source | 2025-02-12T13:46:12.966370 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019884s013lbl.pdf', 'application_number': 19884, 'submission_type': 'SUPPL ', 'submission_number': 13} |
11,803 | 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 | 2025-02-12T13:46:13.010886 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019872Orig1s040lbl.pdf', 'application_number': 19872, 'submission_type': 'SUPPL ', 'submission_number': 40} |
11,807 |
Accupril®
(Quinapril Hydrochloride Tablets)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors
can cause injury and even death to the developing fetus. When pregnancy is
detected, ACCUPRIL should be discontinued as so... | custom-source | 2025-02-12T13:46:13.192776 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019885s028lbl.pdf', 'application_number': 19885, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,808 |
Accupril®
(Quinapril Hydrochloride Tablets)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors
can cause injury and even death to the developing fetus. When pregnancy is
detected, ACCUPRIL should be discontinued as soon as possible. See WARNINGS,
F... | custom-source | 2025-02-12T13:46:13.270185 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019885s033lbl.pdf', 'application_number': 19885, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,805 | 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 | 2025-02-12T13:46:13.290558 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019881s002lbl.pdf', 'application_number': 19881, 'submission_type': 'SUPPL ', 'submission_number': 2} |
11,810 |
Accupril®
(Quinapril Hydrochloride Tablets)
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue ACCUPRIL as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and
death to the developing fetus. See Warnings: Fetal Toxicity
DESCRIP... | custom-source | 2025-02-12T13:46:13.465789 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s038lbl.pdf', 'application_number': 19885, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,809 | Accupril®
(Quinapril Hydrochloride Tablets)
WARNING: FETAL TOXICITY
! When pregnancy is detected, discontinue ACCUPRIL as soon as possible.
! Drugs that act directly on the renin-angiotensin system can cause injury and
death to the developing fetus. See Warnings: Fetal Toxicity
DESCRIPTION
ACCUPRIL® (quinapr... | custom-source | 2025-02-12T13:46:13.538653 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s036lbl.pdf', 'application_number': 19885, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,812 |
Accupril®
(Quinapril Hydrochloride Tablets)
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue ACCUPRIL as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and
death to the developing fetus. See Warnings: Fetal Toxicity
DESCRIPTI... | custom-source | 2025-02-12T13:46:13.595889 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019885s041lbl.pdf', 'application_number': 19885, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,811 |
Accupril®
(Quinapril Hydrochloride Tablets)
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue ACCUPRIL as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and
death to the developing fetus. See Warnings: Fetal Toxicity
DESCRIPTI... | custom-source | 2025-02-12T13:46:13.687572 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s039lbl.pdf', 'application_number': 19885, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,815 |
NDA 19888/S-047
Page 3
ZESTORETIC®
(Lisinopril and Hydrochlorothiazide)
USE IN PREGNANCY
When used in pregnancy, during the second and third trimesters, ACE inhibitors can cause
injury and even death to the developing fetus. When pregnancy is de... | custom-source | 2025-02-12T13:46:13.872284 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s047lbl.pdf', 'application_number': 19888, 'submission_type': 'SUPPL ', 'submission_number': 47} |
11,813 |
Synarel®
(nafarelin acetate)
nasal solution
CENTRAL PRECOCIOUS PUBERTY
(FOR ENDOMETRIOSIS, SEE REVERSE SIDE)
PHYSICIAN LABELING
DESCRIPTION
SYNAREL (nafarelin acetate) Nasal Solution is intended for administration as a spray to
the nasal mucosa. Nafarelin acetate, the active component of SYN... | custom-source | 2025-02-12T13:46:13.974210 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019886s026s027lbl.pdf', 'application_number': 19886, 'submission_type': 'SUPPL ', 'submission_number': 26} |
11,814 |
Synarel®
(nafarelin acetate)
nasal solution
CENTRAL PRECOCIOUS PUBERTY
(FOR ENDOMETRIOSIS, SEE REVERSE SIDE)
PHYSICIAN LABELING
DESCRIPTION
SYNAREL (nafarelin acetate) Nasal Solution is intended for administration as a spray... | custom-source | 2025-02-12T13:46:14.130374 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019886s032lbl.pdf', 'application_number': 19886, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,816 |
ZESTORETIC®
(Lisinopril and Hydrochlorothiazide) Tablets
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue ZESTORETIC as soon as possible.
Drugs that act directly on the renin-angiotensin s... | custom-source | 2025-02-12T13:46:14.196123 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s053lbl.pdf', 'application_number': 19888, 'submission_type': 'SUPPL ', 'submission_number': 53} |
11,817 |
ZESTORETIC®
(lisinopril and hydrochlorothiazide)
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue ZESTORETIC as soon as possible.
Drugs that act directly on the renin-angiotensin system can ... | custom-source | 2025-02-12T13:46:14.332506 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019888s055lbl.pdf', 'application_number': 19888, 'submission_type': 'SUPPL ', 'submission_number': 55} |
11,818 |
ZESTORETIC®
(lisinopril and hydrochlorothiazide)
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
• When pregnancy is detected, discontinue ZESTORETIC as soon as possible.
•... | custom-source | 2025-02-12T13:46:14.489010 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019888s056lbl.pdf', 'application_number': 19888, 'submission_type': 'SUPPL ', 'submission_number': 56} |
11,820 |
Rx only
DILAUDID® ORAL LIQUID
CII
and DILAUDID® 8 mg TABLETS
(hydromorphone hydrochloride)
WARNING: DILAUDID ORAL LIQUID AND DILAUDID 8 MG TABLETS CONTAIN
HYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLED OPIOID
AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE,
OXYMORPHONE, OXYCODONE,... | custom-source | 2025-02-12T13:46:14.589132 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf', 'application_number': 19891, 'submission_type': 'SUPPL ', 'submission_number': 8} |
11,819 |
ZESTORETIC®
(lisinopril and hydrochlorothiazide)
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
• When pregnancy is detected, discontinue ZESTORETIC as soon... | custom-source | 2025-02-12T13:46:14.645002 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019888s065lbl.pdf', 'application_number': 19888, 'submission_type': 'SUPPL ', 'submission_number': 65} |
11,821 |
Rx only
DILAUDID® ORAL LIQUID
CII
and DILAUDID® 8 mg TABLETS
(hydromorphone hydrochloride)
WARNING: DILAUDID ORAL LIQUID AND DILAUDID 8 MG TABLETS CONTAIN
HYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLED OPIOID
AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE,
OXYMORPHONE, OXYCODONE,... | custom-source | 2025-02-12T13:46:14.663547 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf', 'application_number': 19892, 'submission_type': 'SUPPL ', 'submission_number': 9} |
11,822 | DILAUDID® ORAL LIQUID and DILAUDID® TABLETS
(hydromorphone hydrochloride)
CS-II
WARNING: DILAUDID ORAL LIQUID AND DILAUDID TABLETS CONTAIN
HYDROMORPHONE, WHICH IS A POTENT SCHEDULE II CONTROLLED OPIOID
AGONIST. SCHEDULE II OPIOID AGONISTS, INCLUDING MORPHINE,
OXYMORPHONE, OXYCODONE, FENTANYL, AND METHADONE, HAV... | custom-source | 2025-02-12T13:46:14.960322 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019892s015lbl.pdf', 'application_number': 19892, 'submission_type': 'SUPPL ', 'submission_number': 15} |
11,823 | 1
PRAVACHOL®
(pravastatin sodium) Tablets
DESCRIPTION
PRAVACHOL® (pravastatin sodium) is one of a new class of lipid-lowering compounds,
the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents
are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)
reductase, the enzy... | custom-source | 2025-02-12T13:46:15.200484 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19898s50lbl.pdf', 'application_number': 19898, 'submission_type': 'SUPPL ', 'submission_number': 50} |
11,824 | 1
PRAVACHOL®
(pravastatin sodium) Tablets
DESCRIPTION
PRAVACHOL® (pravastatin sodium) is one of a new class of lipid-lowering compounds,
the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents
are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)
reductase, the en... | custom-source | 2025-02-12T13:46:15.251026 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19898slr054_pravachol_lbl.pdf', 'application_number': 19898, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,825 | 1
PRAVACHOL®
(pravastatin sodium) Tablets
DESCRIPTION
PRAVACHOL® (pravastatin sodium) is one of a class of lipid-lowering compounds, the
HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are
competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)
reduct... | custom-source | 2025-02-12T13:46:15.295783 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019898s058lbl.pdf', 'application_number': 19898, 'submission_type': 'SUPPL ', 'submission_number': 58} |
11,826 |
1
Rx only
PRAVACHOL®
(pravastatin sodium) Tablets
DESCRIPTION
PRAVACHOL® (pravastatin sodium) is one of a class of lipid-lowering compounds, the
HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are
competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA... | custom-source | 2025-02-12T13:46:15.446734 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019898s060lbl.pdf', 'application_number': 19898, 'submission_type': 'SUPPL ', 'submission_number': 60} |
11,827 |
... | custom-source | 2025-02-12T13:46:15.759648 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019898s061lbl.pdf', 'application_number': 19898, 'submission_type': 'SUPPL ', 'submission_number': 61} |
11,828 |
... | custom-source | 2025-02-12T13:46:15.835694 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019898s062lbl.pdf', 'application_number': 19898, 'submission_type': 'SUPPL ', 'submission_number': 62} |
11,830 |
... | custom-source | 2025-02-12T13:46:15.966010 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019901s055lbl.pdf', 'application_number': 19901, 'submission_type': 'SUPPL ', 'submission_number': 55} |
11,829 |
... | custom-source | 2025-02-12T13:46:16.111321 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019898s066lbl.pdf', 'application_number': 19898, 'submission_type': 'SUPPL ', 'submission_number': 66} |
11,831 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlight... | custom-source | 2025-02-12T13:46:16.216791 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019901s058lbl.pdf', 'application_number': 19901, 'submission_type': 'SUPPL ', 'submission_number': 58} |
11,833 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ALTACE safely and effectively. See full prescribi... | custom-source | 2025-02-12T13:46:16.344090 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019901s063lbl.pdf', 'application_number': 19901, 'submission_type': 'SUPPL ', 'submission_number': 63} |
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