id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
14,869 |
... | custom-source | 2025-02-12T13:53:55.927842 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 42} |
14,870 |
... | custom-source | 2025-02-12T13:53:56.117344 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021283s046lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 46} |
14,868 |
... | custom-source | 2025-02-12T13:53:56.140268 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s041s042lbl.pdf', 'application_number': 21283, 'submission_type': 'SUPPL ', 'submission_number': 41} |
14,871 |
T2006-56
Ritalin® hydrochloride
methylphenidate hydrochloride
tablets USP
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous... | custom-source | 2025-02-12T13:53:56.240339 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf', 'application_number': 21284, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,872 |
T2006-56
Ritalin® hydrochloride
methylphenidate hydrochloride
tablets USP
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous... | custom-source | 2025-02-12T13:53:56.372850 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf', 'application_number': 21284, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,874 |
T2007-23
Ritalin® hydrochloride
methylphenidate hydrochloride
tablets USP
Ritalin-SR®
methylphenidate hydrochloride USP
sustained-release tablets
Rx only
Prescribing Information
DESCRIPTION
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous... | custom-source | 2025-02-12T13:53:56.503795 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf', 'application_number': 21284, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,873 |
Company logo
Ritalin LA®
(methylphenidate hydrochloride)
extended-release capsules logo
Rx only
Prescribing Information
DESCRIPTION
Methylphenidate hydrochloride is a central nervous system (CNS) stimulant.
Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is an... | custom-source | 2025-02-12T13:53:56.569088 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021284s010lbl.pdf', 'application_number': 21284, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,875 |
company logo
Ritalin LA®
(methylphenidate hydrochloride)
extended-release capsules
Rx only
Prescribing Information
DESCRIPTION
Methylphenidate hydrochloride is a central nervous system (CNS) stimulant.
Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is an extended-re... | custom-source | 2025-02-12T13:53:56.772416 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021284s017lbl.pdf', 'application_number': 21284, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,877 |
Novartis
Ritalin LA®
(methylphenidate hydrochloride)
extended-release capsules
Rx only
Prescribing Information
DESCRIPTION
Methylphenidate hydrochloride is a central nervous system (CNS) stimulant.
Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is an extended-releas... | custom-source | 2025-02-12T13:53:56.866519 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021284s020lbl.pdf', 'application_number': 21284, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,878 |
Ritalin LA®
(methylphenidate hydrochloride)
extended-release capsules
Rx only
Prescribing Information
DESCRIPTION
Methylphenidate hydrochloride is a central nervous system (CNS) stimulant.
Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is an extended-release
formulation of met... | custom-source | 2025-02-12T13:53:57.043975 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021284s023lbl.pdf', 'application_number': 21284, 'submission_type': 'SUPPL ', 'submission_number': 23} |
14,876 |
company logo
Ritalin LA®
(methylphenidate hydrochloride)
extended-release capsules company logo
Rx only
Prescribing Information
DESCRIPTION
Methylphenidate hydrochloride is a central nervous system (CNS) stimulant.
Ritali... | custom-source | 2025-02-12T13:53:57.069127 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021284s019lbl.pdf', 'application_number': 21284, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,879 | NDA 21-285
Page 4
Trileptal ®
(oxcarbazepine)
Tablets
Oral Suspension
Rx only
Prescribing Information
DESCRIPTION
Trileptal® (oxcarbazepine) is an antiepileptic drug available as 150 mg, 300 mg and 600 mg
film-coated tablets for oral administration. Trileptal is also available as a 300 mg/5mL (60
mg/mL) oral suspension... | custom-source | 2025-02-12T13:53:57.180958 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21285lbl.pdf', 'application_number': 21285, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,880 |
HIGHLIGHTS OF PRESCRIBING INFOR... | custom-source | 2025-02-12T13:53:57.425197 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf', 'application_number': 21285, 'submission_type': 'SUPPL ', 'submission_number': 9} |
14,881 |
HIGHLIGHTS OF PRESCRIBING INFOR... | custom-source | 2025-02-12T13:53:57.918892 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf', 'application_number': 21285, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,882 |
HIGHLIGHTS OF PRESCRIBING INFOR... | custom-source | 2025-02-12T13:53:57.935818 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf', 'application_number': 21285, 'submission_type': 'SUPPL ', 'submission_number': 20} |
14,883 |
Novartis logo
TRILEPTAL ®
(oxcarbazepine)
Tablets
Oral Suspension
Rx only
Prescribing Information
DESCRIPTION
Trileptal® (oxcarbazepine) is an antiepileptic drug available as 150 mg, 300 mg and 600 mg
film-coated tablets for oral administration. Trileptal is also available as... | custom-source | 2025-02-12T13:53:58.312707 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021014s026,021285s021lbl.pdf', 'application_number': 21285, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,884 |
HIGHLIGHTS OF PRESCRIBING INFOR... | custom-source | 2025-02-12T13:53:58.372395 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf', 'application_number': 21285, 'submission_type': 'SUPPL ', 'submission_number': 22} |
14,886 | NDA 21-286
Page 4
BENICAR™ Tablets
(OLMESARTAN MEDOXOMIL)
DESCRIPTION
BENICAR™ (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from
the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.
Olmesartan medo... | custom-source | 2025-02-12T13:53:58.559469 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21286lbl.pdf', 'application_number': 21286, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,887 | NDA 21-286/S-010
Page 3
Benicar Tablets
(OLMESARTAN MEDOXOMIL)
DESCRIPTION
Benicar (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the
gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.
Olmesartan medo... | custom-source | 2025-02-12T13:53:58.651631 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021286s010lbl.pdf', 'application_number': 21286, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,885 |
... | custom-source | 2025-02-12T13:53:58.677506 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s033,021285s027lbl.pdf', 'application_number': 21285, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,888 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to ... | custom-source | 2025-02-12T13:53:58.925773 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021286s018lbl.pdf', 'application_number': 21286, 'submission_type': 'SUPPL ', 'submission_number': 18} |
14,891 | 12 June 2003
1
FINAL
ALFUZOSIN PACKAGE INSERT
12 JUNE 2003
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
12 June 2003
2
UROXATRAL™
(alfuzosin HCl extended-release tablets)
DESCRIPTION
Each UROXATRAL (alfuzosin HCl extended-release tabl... | custom-source | 2025-02-12T13:53:59.010488 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21287_uroxatral_lbl.pdf', 'application_number': 21287, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,890 |
... | custom-source | 2025-02-12T13:53:59.132663 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021286s030lbl.pdf', 'application_number': 21286, 'submission_type': 'SUPPL ', 'submission_number': 30} |
14,889 |
... | custom-source | 2025-02-12T13:53:59.202861 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021286s027lbl.pdf', 'application_number': 21286, 'submission_type': 'SUPPL ', 'submission_number': 27} |
14,892 | NDA 21-287/S-005
Page 3
UROXATRAL®
(alfuzosin HCl extended-release tablets)
DESCRIPTION
Each UROXATRAL (alfuzosin HCl extended-release tablets) tablet contains 10 mg alfuzosin
hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline
powder that melts at approxima... | custom-source | 2025-02-12T13:53:59.403552 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s005lbl.pdf', 'application_number': 21287, 'submission_type': 'SUPPL ', 'submission_number': 5} |
14,893 | 1
UROXATRAL®
(alfuzosin HCl extended-release tablets)
DESCRIPTION
Each UROXATRAL (alfuzosin HCl extended-release tablets) tablet contains 10 mg alfuzosin
hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white
crystalline powder that melts at approximately 240°C. It is freely ... | custom-source | 2025-02-12T13:53:59.450097 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s007lbl.pdf', 'application_number': 21287, 'submission_type': 'SUPPL ', 'submission_number': 7} |
14,894 |
UROXATRAL®
(alfuzosin HCl extended-release tablets)
DESCRIPTION
Each UROXATRAL (alfuzosin HCl extended-release tablets) tablet contains 10 mg alfuzosin
hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white
crystalline powder that melts at approximately 240°C. It is freely sol... | custom-source | 2025-02-12T13:53:59.600287 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021287s008lbl.pdf', 'application_number': 21287, 'submission_type': 'SUPPL ', 'submission_number': 8} |
14,895 |
UROXATRAL®
(alfuzosin HCl extended-release tablets)
DESCRIPTION
Each UROXATRAL (alfuzosin HCl extended-release tablets) tablet contains 10 mg alfuzosin
hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white
crystalline powder that melts at approximately 240°C. I... | custom-source | 2025-02-12T13:53:59.605738 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021287s011lbl.pdf', 'application_number': 21287, 'submission_type': 'SUPPL ', 'submission_number': 11} |
14,896 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the informatio... | custom-source | 2025-02-12T13:53:59.786696 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021287s013lbl.pdf', 'application_number': 21287, 'submission_type': 'SUPPL ', 'submission_number': 13} |
14,899 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not ... | custom-source | 2025-02-12T13:54:00.033753 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021287s017lbl.pdf', 'application_number': 21287, 'submission_type': 'SUPPL ', 'submission_number': 17} |
14,897 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information neede... | custom-source | 2025-02-12T13:54:00.127944 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s014lbl.pdf', 'application_number': 21287, 'submission_type': 'SUPPL ', 'submission_number': 14} |
14,901 |
__________________________________________________________________________________________
... | custom-source | 2025-02-12T13:54:00.419294 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020715s024,021288s021,022437s002lbl.pdf', 'application_number': 21288, 'submission_type': 'SUPPL ', 'submission_number': 21} |
14,898 |
8
USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal impairment
8.7 Hepatic impairment
10
OVERDOSAGE
11
DESCRIPTION
12
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
1... | custom-source | 2025-02-12T13:54:00.429333 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s016lbl.pdf', 'application_number': 21287, 'submission_type': 'SUPPL ', 'submission_number': 16} |
14,902 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRELSTAR safely and
effectively. See full prescribing information for TRELSTAR.
TRELSTAR® (triptorelin pamoate for injectable suspension)
Intramuscular use.
Initial U.S. Approval: 2000
--------------RECENT ... | custom-source | 2025-02-12T13:54:00.659454 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020715s032,021288s028,022437s008lbl.pdf', 'application_number': 21288, 'submission_type': 'SUPPL ', 'submission_number': 28} |
14,900 |
... | custom-source | 2025-02-12T13:54:00.705342 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf', 'application_number': 21287, 'submission_type': 'SUPPL ', 'submission_number': 18} |
14,904 | TRACLEERTM
[bosentan]
62.5 mg and 125 mg film-coated tablets
Use of TRACLEER™ requires attention to two sig-
nificant concerns: 1) potential for serious liver
injury, and 2) potential damage to a fetus.
WARNING: Potential liver injury
TRACLEER™ causes at least 3-fold (upper limit of
normal; ULN) elevation of liver amin... | custom-source | 2025-02-12T13:54:01.193708 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21290lbl.pdf', 'application_number': 21290, 'submission_type': 'ORIG ', 'submission_number': 1} |
14,903 |
... | custom-source | 2025-02-12T13:54:01.433602 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021289s019lbl.pdf', 'application_number': 21289, 'submission_type': 'SUPPL ', 'submission_number': 19} |
14,905 | TRACLEER®
[bosentan]
62.5 mg and 125 mg film-coated tablets
Use of TRACLEER® requires attention to two significant concerns: 1) potential for
serious liver injury, and 2) potential damage to a fetus.
WARNING: Potential liver injury
TRACLEER® causes at least 3-fold (upper limit of normal; ULN) elevation of liver
aminotr... | custom-source | 2025-02-12T13:54:01.529125 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21290se8-001_tracleer_lbl.pdf', 'application_number': 21290, 'submission_type': 'SUPPL ', 'submission_number': 1} |
14,906 | NDA 21-290/S-006 and S-007
Page 3
TRACLEER®
[bosentan]
62.5 mg and 125 mg film-coated tablets
Use of TRACLEER® requires attention to two significant concerns: 1) potential for serious liver injury,
and 2) potential damage to a fetus.
WARNING: Potential liver injury
TRACLEER® causes at least 3-fold (uppe... | custom-source | 2025-02-12T13:54:01.918599 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021290s006,007lbl.pdf', 'application_number': 21290, 'submission_type': 'SUPPL ', 'submission_number': 6} |
14,909 |
TRACLEER®
[bosentan]
62.5 mg and 125 mg film-coated tablets
Use of TRACLEER® requires attention to two significant concerns: 1) potential for serious liver injury,
and 2) potential damage to a fetus.
WARNING: Potential liver injury
TRACLEER® causes at le... | custom-source | 2025-02-12T13:54:02.006833 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s015lbl.pdf', 'application_number': 21290, 'submission_type': 'SUPPL ', 'submission_number': 15} |
14,907 | NDA 21-290/S-010
Page 3
TRACLEER®
[bosentan]
62.5 mg and 125 mg film-coated tablets
Use of TRACLEER® requires attention to two significant concerns: 1) potential for serious liver injury,
and 2) potential damage to a fetus.
WARNING: Potential liver injury
TRACLEER® causes at least 3-fold (upper limit of... | custom-source | 2025-02-12T13:54:02.090622 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021290s010lbl.pdf', 'application_number': 21290, 'submission_type': 'SUPPL ', 'submission_number': 10} |
14,908 |
TRACLEER®
[bosentan]
62.5 mg and 125 mg film-coated tablets
Use of TRACLEER® requires attention to two significant concerns: 1) potential for serious liver injury
and 2) potential damage to a fetus.
WARNING: Potential liver injury
TRACLEER® causes at l... | custom-source | 2025-02-12T13:54:02.191603 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s014lbl.pdf', 'application_number': 21290, 'submission_type': 'SUPPL ', 'submission_number': 14} |
15,123 |
_________________
_______________
______________
______________
______________
_______________
... | custom-source | 2025-02-12T13:54:02.481333 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021290s025lbl.pdf', 'application_number': 21290, 'submission_type': 'SUPPL ', 'submission_number': 25} |
15,125 | Letter date 05.27.2002 NDA 21-292
NOVOTHYROX
(levothyroxine sodium tablets, USP)
Rx only
DESCRIPTION
NOVOTHYROX (levothyroxine sodium tablets, USP) contains synthetic crystalline L-
3,3’,5,5’-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is
identical to that produced in the human thyroid ... | custom-source | 2025-02-12T13:54:02.624474 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21292lbl.pdf', 'application_number': 21292, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,127 | Page 1/20
Asimia (paroxetine mesylate)Tablets
Attachment – Tentative Approval Labeling
NDA 21-299
Prescribing Information
ASIMIATM
Brand of
PAROXETINE (as mesylate) tablets
DESCRIPTION
ASIMIATM (paroxetine mesylate) is an orally administered psychotropic drug with a chemical structure related
to paroxetine hydrochlorid... | custom-source | 2025-02-12T13:54:03.047352 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21299lbl.pdf', 'application_number': 21299, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,126 | CLARINEX ®
(desloratadine)
TABLETS
DESCRIPTION: CLARINEX (desloratadine) Tablets are light blue, round, film
coated tablets containing 5 mg desloratadine, an antihistamine, to be administered
orally. It also contains the following excipients: dibasic calcium phosphate dihydrate
USP, microcrystalline cellulose NF, corn ... | custom-source | 2025-02-12T13:54:03.102925 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21297lbl.pdf', 'application_number': 21297, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,124 |
_________________
_________________
_______________
______________
... | custom-source | 2025-02-12T13:54:03.437543 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021290s029lbl.pdf', 'application_number': 21290, 'submission_type': 'SUPPL ', 'submission_number': 29} |
15,129 |
NDA 21-299
Page 1
Date of Issuance:01/2008, PI-2000-10
1
Prescribing Information
PEXEVA
®
Brand of
(paroxetine mesylate) tablets
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in
children, adolescents, and young... | custom-source | 2025-02-12T13:54:04.029508 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021299s021lbl.pdf', 'application_number': 21299, 'submission_type': 'SUPPL ', 'submission_number': 21} |
15,128 |
NDA 21-299
Page 1
Date of Issuance: (Date to be Added Upon Approval), PI-2000-7
Prescribing Information
PEXEVA®
Brand of
(paroxetine mesylate) tablets
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (... | custom-source | 2025-02-12T13:54:04.088085 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021299s016,s017,s018lbl.pdf', 'application_number': 21299, 'submission_type': 'SUPPL ', 'submission_number': 17} |
15,130 |
Prescribing Information
PEXEVA
®
Brand of
(paroxetine mesylate) tablets
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in
... | custom-source | 2025-02-12T13:54:04.710817 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021299s022lbl.pdf', 'application_number': 21299, 'submission_type': 'SUPPL ', 'submission_number': 22} |
15,132 |
PEXEVA®
Brand of
(paroxetine mesylate) tablets
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) and other psyc... | custom-source | 2025-02-12T13:54:04.803719 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021299s032lbl.pdf', 'application_number': 21299, 'submission_type': 'SUPPL ', 'submission_number': 32} |
15,134 |
Levoxyl (levothyroxine sodium) Tablet
[King Pharmaceuticals, Inc.]
DESCRIPTION
–LEVOXYL® (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3’,5,5’
tetraiodothyronine sodium salt [levothyroxine (T ) sodium]. Synthetic T is identical t... | custom-source | 2025-02-12T13:54:05.632205 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021301s026lbl.pdf', 'application_number': 21301, 'submission_type': 'SUPPL ', 'submission_number': 26} |
15,131 |
Prescribing Information
PEXEVA
®
Brand of
(paroxetine mesylate) tablets
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in
... | custom-source | 2025-02-12T13:54:05.961540 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021299s023lbl.pdf', 'application_number': 21299, 'submission_type': 'SUPPL ', 'submission_number': 23} |
15,122 |
_________________
_______________
______________
______________
______________
... | custom-source | 2025-02-12T13:54:05.969270 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021290s016lbl.pdf', 'application_number': 21290, 'submission_type': 'SUPPL ', 'submission_number': 16} |
15,136 | NDA 21-302/S-005
Page 3
T2003-01
89012002
Elidel®
(pimecrolimus) Cream 1%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
Rx only
Prescribing Information
DESCRIPTION
Elidel® (pimecrolimus) Cream 1% contains the compound pimecrolimus, the 33-epi-chloro-derivative
of the macrolactam ascomycin.
... | custom-source | 2025-02-12T13:54:06.412789 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21302s005lbl.pdf', 'application_number': 21302, 'submission_type': 'SUPPL ', 'submission_number': 5} |
15,135 |
... | custom-source | 2025-02-12T13:54:06.471912 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021301s027lbl.pdf', 'application_number': 21301, 'submission_type': 'SUPPL ', 'submission_number': 27} |
15,137 |
Elidel®
(pimecrolimus) Cream 1%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
Rx only
Prescribing Information
See WARNINGS, boxed WARNING concerning long-term safety of topical
calcineurin inhibitors.
DESCRIPTION
ELIDEL® (pimecrolimus) Cream 1% contains the compound pimecrolimus, the
immunosuppres... | custom-source | 2025-02-12T13:54:06.554077 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021302s012lbl.pdf', 'application_number': 21302, 'submission_type': 'SUPPL ', 'submission_number': 12} |
15,133 |
... | custom-source | 2025-02-12T13:54:06.730551 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021165s017,021300s014,021312s015,021563s003lbl.pdf', 'application_number': 21300, 'submission_type': 'SUPPL ', 'submission_number': 14} |
15,139 | 1
[Attachment to FDA Approval Letter for NDA 21-303/S-001]
ADDERALL XR CAPSULES
CII Rx
Only
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE.
PA... | custom-source | 2025-02-12T13:54:07.053187 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21303s1lbl.pdf', 'application_number': 21303, 'submission_type': 'SUPPL ', 'submission_number': 1} |
15,138 |
... | custom-source | 2025-02-12T13:54:07.101342 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021302s018lbl.pdf', 'application_number': 21302, 'submission_type': 'SUPPL ', 'submission_number': 18} |
15,140 |
1
ADDERALL XR CAPSULES
CII Rx Only
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSS... | custom-source | 2025-02-12T13:54:07.103759 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021303s005lbl.pdf', 'application_number': 21303, 'submission_type': 'SUPPL ', 'submission_number': 5} |
15,141 |
1
ADDERALL® XR CAPSULES
CII Rx Only
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY ... | custom-source | 2025-02-12T13:54:07.256462 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021303s009lbl.pdf', 'application_number': 21303, 'submission_type': 'SUPPL ', 'submission_number': 9} |
15,144 | MEDICATION GUIDE
ADDERALL XR® (ADD-ur-all X-R) CII
Read the Medication Guide that comes with ADDERALL XR® before you or your child starts taking it and each time you get a refill.
There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child’s
treat... | custom-source | 2025-02-12T13:54:07.586806 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021303s015lbl.pdf', 'application_number': 21303, 'submission_type': 'SUPPL ', 'submission_number': 15} |
15,142 | NDA 21-303/S-010
Page 3
ADDERALL® XR CAPSULES
CII Rx Only
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE.
PARTICULAR ATTENTION SHOULD BE PAI... | custom-source | 2025-02-12T13:54:07.724153 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021303s010lbl.pdf', 'application_number': 21303, 'submission_type': 'SUPPL ', 'submission_number': 10} |
15,143 | NDA 11-522/S-034 and S-037
NDA 21-303/S-013
Page 3
ADDERALL® CII
Rx ONLY
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID
TO THE POSSIBILITY OF SUBJECTS OBTAININ... | custom-source | 2025-02-12T13:54:07.942377 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf', 'application_number': 21303, 'submission_type': 'SUPPL ', 'submission_number': 13} |
15,145 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use ADDERALL XR safely and effectively. See full
prescribing infor... | custom-source | 2025-02-12T13:54:07.950693 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022lbl.pdf', 'application_number': 21303, 'submission_type': 'SUPPL ', 'submission_number': 20} |
15,146 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use ADDERALL XR safely and effectively. See f... | custom-source | 2025-02-12T13:54:08.276086 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s024lbl.pdf', 'application_number': 21303, 'submission_type': 'SUPPL ', 'submission_number': 24} |
15,148 | 03/29/01
c:\windows\desktop\21304lbl.docc:\windows\temp\010329cleanfinallabel2.doc
VALCYTE
(valganciclovir hydrochloride tablets)
WARNING:
THE CLINICAL TOXICITY OF VALCYTE, WHICH IS METABOLIZED TO
GANCICLOVIR, INCLUDES GRANULOCYTOPENIA, ANEMIA AND
THROMBOCYTOPENIA. IN ANIMAL STUDIES GANCICLOVIR WAS CARCINOGENIC,
TER... | custom-source | 2025-02-12T13:54:08.626109 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21304lbl.pdf', 'application_number': 21304, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,147 |
... | custom-source | 2025-02-12T13:54:08.657352 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021303s027lbl.pdf', 'application_number': 21303, 'submission_type': 'SUPPL ', 'submission_number': 27} |
15,149 | NDA 21-304/S-001
Page 6
VALCYTE
(valganciclovir hydrochloride tablets)
Rx only
WARNING
THE CLINICAL TOXICITY OF VALCYTE, WHICH IS METABOLIZED TO
GANCICLOVIR,
INCLUDES
GRANULOCYTOPENIA,
ANEMIA
AND
THROMBOCYTOPENIA.
IN ANIMAL
STUDIES
GANCICLOVIR
WAS
CARCINOGENIC, TERATOGENIC AND CAUSED ASPER... | custom-source | 2025-02-12T13:54:08.724866 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21304se1-001_valcyte_lbl.pdf', 'application_number': 21304, 'submission_type': 'SUPPL ', 'submission_number': 1} |
15,150 |
_____________________________... | custom-source | 2025-02-12T13:54:08.963723 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021304s007,022257s000lbl.pdf', 'application_number': 21304, 'submission_type': 'SUPPL ', 'submission_number': 7} |
15,152 | SUPPLEMENTAL NEW DRUG APPLICATION (S/NDA) NDA 21-305
DRAXIMAGE SODIUM IODIDE I 131 CAPSULES USP - DIAGNOSTIC ORAL
Sodium Iodide I 131 Capsules USP
Diagnostic - Oral
DESCRIPTION
Sodium Iodide I 131 Capsules USP for diagnostic use is a radiopharmaceutical containing
Sodium Iodide I-131 and supplied for o... | custom-source | 2025-02-12T13:54:09.053464 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021305s003lbl.pdf', 'application_number': 21305, 'submission_type': 'SUPPL ', 'submission_number': 3} |
15,151 | NDA 21-305
Page 3
Kit for the Preparation of Sodium Iodide I-131 Capsules and Solution USP
Therapeutic - Oral
DESCRIPTION
This kit provides a solution of Sodium Iodide I-131 with a radioconcentration of 37 GBq/mL
(1000 mCi/mL). Each mL of the concentrated solution contains 37 GBq of no-carrier added
So... | custom-source | 2025-02-12T13:54:09.088052 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21305_Sodium-Iodide_lbl.pdf', 'application_number': 21305, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,154 |
HICON™
Kit for the Preparation of Sodium Iodide I 131
Capsules and Solution USP
Therapeutic – Oral
DESCRIPTION
HICON™ is a kit which provides a solution of Sodium Iodide I-131 with a radioconcentration of 37 gigabecquerels/mL
(1,000 millicuries/mL). Each mL of the concen... | custom-source | 2025-02-12T13:54:09.368977 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021305s027lbl.pdf', 'application_number': 21305, 'submission_type': 'SUPPL ', 'submission_number': 27} |
15,155 | Application NDA 21305 This document contains: Label for SODIUM IODIDE I 131 CAPSULES
DIAGNOSTIC [Supplement 041, Action Date 6/15/2016]
Also available: Label for HICON [Supplement 42, Action Date 7/8/2016]
This label may not be the latest approved by FDA.
For current labeling information, please visit https://w... | custom-source | 2025-02-12T13:54:09.522313 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021305s041lbl.pdf', 'application_number': 21305, 'submission_type': 'SUPPL ', 'submission_number': 41} |
15,153 |
DRAXIMAGE SODIUM IODIDE I 131 CAPSULES USP - DIAGNOSTIC ORAL
Sodium Iodide I 131 Capsules USP
Diagnostic - Oral
DESCRIPTION
Sodium Iodide I 131 Capsules USP for diagnostic use is a radiopharmaceutical containing
Sodium Iodide I-131 and supplied for oral administration in a gelatin capsule. Each capsu... | custom-source | 2025-02-12T13:54:09.771133 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021305s005lbl.pdf', 'application_number': 21305, 'submission_type': 'SUPPL ', 'submission_number': 5} |
15,156 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to ... | custom-source | 2025-02-12T13:54:10.240627 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021306s000lbl.pdf', 'application_number': 21306, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,157 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
... | custom-source | 2025-02-12T13:54:10.359415 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021306s001s003lbl.pdf', 'application_number': 21306, 'submission_type': 'SUPPL ', 'submission_number': 3} |
15,158 | 6BHIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
BUTRANS® safely and effectively. See full prescribing information for
BUTRANS.
BUTRANS® (buprenorphine) Transdermal System for transdermal
administration CIII
Initial U.S. Approval: 1981
... | custom-source | 2025-02-12T13:54:10.577662 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s015s019lbl.pdf', 'application_number': 21306, 'submission_type': 'SUPPL ', 'submission_number': 15} |
15,160 |
6BHIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do no... | custom-source | 2025-02-12T13:54:10.847659 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021306s018lbl.pdf', 'application_number': 21306, 'submission_type': 'SUPPL ', 'submission_number': 18} |
15,162 | Brand
Category
Product Variant
Component Type
Consumer Unit Contents
Copy & Graphics Number xxxxxx
GGM# / Version
xxxxxxx /4
Date
- MONISTAT
- VAGINAL ANTIFUNGAL
- COMBINATION PACK
- OUTER CARTON
- Combo
6/22/01
Family of Companies
199 Grandview Road
Skillman, NJ 08558-9418
908-874-1666 (... | custom-source | 2025-02-12T13:54:11.052642 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/021308Orig1s000lbl.pdf', 'application_number': 21308, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,159 |
6BHIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include a... | custom-source | 2025-02-12T13:54:11.348376 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021306s016lbl.pdf', 'application_number': 21306, 'submission_type': 'SUPPL ', 'submission_number': 16} |
15,163 | CLARINEX® REDITAB TABLET
PAGE 1
JUNE 26 2002
NDA 21-312
FINAL DRAFT LABELING
CLARINEX ®
1
(desloratadine)
2
TABLETS, REDITABS TABLETS
3
4
DESCRIPTION: CLARINEX (desloratadine) Tablets are light blue, round, film
5
coated tablets containing 5 mg desloratadine, an antihistamine, to be administered
6
orally. It also conta... | custom-source | 2025-02-12T13:54:11.409149 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21312lbl.pdf', 'application_number': 21312, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,164 |
PAGE 1
CLARINEX®
(desloratadine)
TABLETS, SYRUP, REDITABS® TABLETS
DESCRIPTION: CLARINEX (desloratadine) Tablets are light blue, round, film
coated tablets containing 5 mg desloratadine, an antihistamine, to be administered
orally. It also contains the following excipients: dibasic calc... | custom-source | 2025-02-12T13:54:11.448344 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021312s006lbl.pdf', 'application_number': 21312, 'submission_type': 'SUPPL ', 'submission_number': 6} |
15,167 | CLARINEX-D
® 12 HOUR EXTENDED RELEASE TABLETS
SECTION 2
PAGE 1
LABELING
CLARINEX-D® 12 HOUR
PRODUCT
1
(desloratadine 2.5 mg and pseudoephedrine sulfate, USP 120 mg) INFORMATION
2
EXTENDED RELEASE TABLETS
3
4
DESCRIPTION: CLARINEX-D® 12 HOUR Extended Release Tablets are oval
5
shaped blue and white ... | custom-source | 2025-02-12T13:54:11.833242 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021313s001lbl.pdf', 'application_number': 21313, 'submission_type': 'SUPPL ', 'submission_number': 1} |
15,165 | CLARINEX
® TABLETS
CLARINEX
® SYRUP
PAGE 1
CLARINEX
® REDITABS
® TABLET
MARCH 2005
CLARINEX ®
1
(desloratadine)
2
TABLETS, SYRUP, REDITABS® TABLETS
3
4
DESCRIPTION: CLARINEX (desloratadine) Tablets are light blue, round, film
5
coated tablets containing 5 mg desloratadine, an antihistamine, t... | custom-source | 2025-02-12T13:54:12.020564 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021312s007lbl.pdf', 'application_number': 21312, 'submission_type': 'SUPPL ', 'submission_number': 7} |
15,166 | CLARINEX-D
® 12 HOUR EXTENDED RELEASE TABLETS
SECTION 2
PAGE 1
LABELING
CLARINEX-D® 12 HOUR
PRODUCT
1
(desloratadine 2.5 mg and pseudoephedrine sulfate, USP 120 mg) INFORMATION
2
EXTENDED RELEASE TABLETS
3
4
DESCRIPTION: CLARINEX-D® 12 HOUR Extended Release Tablets are oval
5
shaped blue and white ... | custom-source | 2025-02-12T13:54:12.080814 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021313s000lbl.pdf', 'application_number': 21313, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,168 |
DOCUMENT INFORMATION PAGE
DARRTS COMMUNICATION
This page is for FDA internal use only. Do NOT send this page with the letter.
Application #(s): NDA 21-314/S-004
Communication Type: Correspondence
Communication
Group: sNDA Action
Communication Name: Approval
Communication ID: COR-SNDAACTION-05
Drafted... | custom-source | 2025-02-12T13:54:12.687628 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021314s004.pdf', 'application_number': 21314, 'submission_type': 'SUPPL ', 'submission_number': 4} |
15,170 |
ALTOPREV®
lovastatin extended-release tablets
DESCRIPTION
ALTOPREV® lovastatin extended-release tablets contain a cholesterol-lowering agent isolated
from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone,
is hydrolyzed to the corres... | custom-source | 2025-02-12T13:54:13.037529 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s026lbl.pdf', 'application_number': 21316, 'submission_type': 'SUPPL ', 'submission_number': 26} |
15,169 | NDA 21-316/S-001
Page 3
ALTOCOR
Extended-Release Tablets
(Lovastatin)
DESCRIPTION
ALTOCOR (Lovastatin) Extended-Release Tablets contain a cholesterol-lowering agent isolated
from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is
hydrolyzed to the c... | custom-source | 2025-02-12T13:54:13.144670 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316s1lbl.pdf', 'application_number': 21316, 'submission_type': 'SUPPL ', 'submission_number': 1} |
15,171 |
___________________________________________________________________________________________________________... | custom-source | 2025-02-12T13:54:13.265688 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s028lbl.pdf', 'application_number': 21316, 'submission_type': 'SUPPL ', 'submission_number': 28} |
15,172 |
ALTOPREV®
lovastatin extended-release tablets
DESCRIPTION
ALTOPREV® lovastatin extended-release tablets contain a cholesterol-lowering agent isolated
from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone,
is hydrolyzed to the corresponding ... | custom-source | 2025-02-12T13:54:13.543099 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s029lbl.pdf', 'application_number': 21316, 'submission_type': 'SUPPL ', 'submission_number': 29} |
15,173 | 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 | 2025-02-12T13:54:13.561266 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21317lbl.pdf', 'application_number': 21317, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,174 | PA 9241 FSAMP
FORTEO
teriparatide (rDNA origin) injection
750 mcg/3 mL
WARNING
In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma
(a malignant bone tumor) that was dependent on dose and treatment duration. The effect
was observed at systemic exposures to teriparatide rangin... | custom-source | 2025-02-12T13:54:13.720408 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21318_forteo_lbl.pdf', 'application_number': 21318, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,177 |
1
PA 9244FSAMP
FORTEO®
teriparatide (rDNA origin) injection
750 mcg/3 mL
WARNING
In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma
(a malignant bone tumor) that was dependent on dose and treatment duration. The effect
was observed at systemic exposures to teriparatide ran... | custom-source | 2025-02-12T13:54:14.034481 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021318s015lbl.pdf', 'application_number': 21318, 'submission_type': 'SUPPL ', 'submission_number': 15} |
15,176 |
1
PA 9292 FSAMP
_______________________________________________________________________
User Manual
FORTEO™
teriparatide (rDNA origin) injection
Prefilled Delivery Device
__________________________________________________________________
Instructions for Use
Before using FORTEO, please read and follow th... | custom-source | 2025-02-12T13:54:14.079204 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021318s009lbl.pdf', 'application_number': 21318, 'submission_type': 'SUPPL ', 'submission_number': 9} |
15,175 | User Manual
FORTEO
™
teriparatide (rDNA origin) injection
Prefilled Delivery Device
Instructions for Use
Before using FORTEO, please read and follow these instructions
carefully.
If you do not follow these instructions carefully, you may get the
wrong FORTEO dose. Also, read the Medication Guide inside your
FORTEO cart... | custom-source | 2025-02-12T13:54:14.266212 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318slr002_forteo_lbl.pdf', 'application_number': 21318, 'submission_type': 'SUPPL ', 'submission_number': 2} |
15,161 | 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 | 2025-02-12T13:54:14.276401 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021307Orig1s015lbl.pdf', 'application_number': 21307, 'submission_type': 'SUPPL ', 'submission_number': 15} |
15,178 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FORTEO safely and effectively. See full prescribing information
for FORTEO... | custom-source | 2025-02-12T13:54:14.650567 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021318s036lbl.pdf', 'application_number': 21318, 'submission_type': 'SUPPL ', 'submission_number': 36} |
15,180 | NDA 21-319/S-008
Page 3
PRESCRIBING INFORMATION
AVODART™
(dutasteride)
Soft Gelatin Capsules
DESCRIPTION
AVODART (dutasteride) is a synthetic 4-azasteroid compound that is a selective inhibitor of
both the type 1 and type 2 isoforms of steroid 5α-reductase (5AR), an intracellular enzyme that
converts testo... | custom-source | 2025-02-12T13:54:14.732951 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s008lbl.pdf', 'application_number': 21319, 'submission_type': 'SUPPL ', 'submission_number': 8} |
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