id int64 737 80.8k | text stringlengths 1 1.03M โ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
80,140 |
... | custom-source | 2025-02-12T15:46:30.019663 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s023lbl.pdf', 'application_number': 213051, 'submission_type': 'SUPPL ', 'submission_number': 23} |
80,138 |
... | custom-source | 2025-02-12T15:46:30.054107 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf', 'application_number': 215866, 'submission_type': 'SUPPL ', 'submission_number': 10} |
80,144 |
... | custom-source | 2025-02-12T15:46:30.981240 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125319s110lbl.pdf', 'application_number': 125319, 'submission_type': 'SUPPL ', 'submission_number': 110} |
80,142 |
... | custom-source | 2025-02-12T15:46:31.412510 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209637s032lbl.pdf', 'application_number': 209637, 'submission_type': 'SUPPL ', 'submission_number': 32} |
80,146 |
... | custom-source | 2025-02-12T15:46:31.522028 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219015s000lbl.pdf', 'application_number': 219015, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,147 |
... | custom-source | 2025-02-12T15:46:31.691833 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214938s004lbl.pdf', 'application_number': 214938, 'submission_type': 'SUPPL ', 'submission_number': 4} |
80,148 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CADUET safely and effectively. See full prescribing information for
CADUET.
CADUETยฎ (amlodipine and atorvastatin) tablets, for oral use
Initial U.S. Approval: 2004
----------------------------RECENT MAJOR CHANG... | custom-source | 2025-02-12T15:46:32.167671 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021540s050lbl.pdf', 'application_number': 21540, 'submission_type': 'SUPPL ', 'submission_number': 50} |
80,149 |
... | custom-source | 2025-02-12T15:46:32.991626 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022433s037lbl.pdf', 'application_number': 22433, 'submission_type': 'SUPPL ', 'submission_number': 37} |
80,176 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NOREPINEPHRINE BITARTRATE IN DEXTROSE injection safely
and effectively. See full prescribing information for
NOREPINEPHRINE BITARTRATE IN DEXTROSE injection.
NOREPINEPHRINE BITARTRATE IN DEXTROSE injecti... | custom-source | 2025-02-12T15:46:33.109410 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214313Orig1s003lbl.pdf', 'application_number': 214313, 'submission_type': 'SUPPL ', 'submission_number': 3} |
80,151 |
... | custom-source | 2025-02-12T15:46:33.425957 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211243s015lbl.pdf', 'application_number': 211243, 'submission_type': 'SUPPL ', 'submission_number': 15} |
80,177 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INFUVITE ADULT safely and effectively. See full prescribing
information for INFUVITE ADULT
INFUVITE ADULT (multiple vitamins injection), for intravenous use
Initial U.S. Approval: 2003
----------------------... | custom-source | 2025-02-12T15:46:33.429585 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021163s045lbl.pdf', 'application_number': 21163, 'submission_type': 'SUPPL ', 'submission_number': 45} |
80,178 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INFUVITE PEDIATRIC safely and effectively. See full prescribing
information for INFUVITE PEDIATRIC.
INFUVITE PEDIATRIC (multiple vitamins injection), for intravenous
use
Initial U.S. Approval: 2001
---------... | custom-source | 2025-02-12T15:46:33.672523 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021265s044lbl.pdf', 'application_number': 21265, 'submission_type': 'SUPPL ', 'submission_number': 44} |
80,181 | AmBisomeยฎ
(amphotericin B) liposome for injection
DESCRIPTION
AmBisomeยฎ for Injection is a sterile, non-pyrogenic lyophilized product for intravenous
infusion. Each vial contains amphotericin B 50 milligrams (mg), intercalated into a
liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cho... | custom-source | 2025-02-12T15:46:33.969319 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050740Orig1s037Lbl.pdf', 'application_number': 50740, 'submission_type': 'SUPPL ', 'submission_number': 37} |
80,183 |
... | custom-source | 2025-02-12T15:46:34.582782 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210807s013lbl.pdf', 'application_number': 210807, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,182 |
... | custom-source | 2025-02-12T15:46:34.688111 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210806s011lbl.pdf', 'application_number': 210806, 'submission_type': 'SUPPL ', 'submission_number': 11} |
80,189 |
... | custom-source | 2025-02-12T15:46:35.103929 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s011lbl.pdf', 'application_number': 214662, 'submission_type': 'SUPPL ', 'submission_number': 11} |
80,184 |
HIGHLIGHTS OF PRESCRIBING ... | custom-source | 2025-02-12T15:46:35.302061 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219293s000lbl.pdf', 'application_number': 219293, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,200 | Proposed Draft Labeling
NDA 22-032
Omeprazole Delayed Release Tablets, 20 mg
14 Tablets (Blister Foil)
Location for
lot number and
expiration date
91574 00 X9
Mfd. by: Dexcel Pharma Technologies Ltd., 10 Hakidma St., Yokneam Illit, 2069200, Israel
READ WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP OUTER CARTON F... | custom-source | 2025-02-12T15:46:35.581665 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022032Orig1s065lbl.pdf', 'application_number': 22032, 'submission_type': 'SUPPL ', 'submission_number': 65} |
80,190 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LINEZOLID injection safely and effectively. See full prescribing
information for LINEZOLID injection.
LINEZOLID injection, for intravenous use
Initial U.S... | custom-source | 2025-02-12T15:46:35.863733 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206473s010lbl.pdf', 'application_number': 206473, 'submission_type': 'SUPPL ', 'submission_number': 10} |
80,191 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AYVAKIT safely and effectively. See full prescribing information for
AYVAKIT.
AYVAKITยฎ (avapritinib) tablets, for oral use
Initial U.S. Approval: 2020
-----------... | custom-source | 2025-02-12T15:46:36.065288 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212608s020lbl.pdf', 'application_number': 212608, 'submission_type': 'SUPPL ', 'submission_number': 20} |
80,205 |
I
I
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RYSTIGGO safely and effectively. See full prescribing information
for RYSTIGGO.
RYSTIGGOยฎ (rozanolixizumab-noli) injection, for subcutaneous
use
Initial U.S. Approval: 2023
---------------------... | custom-source | 2025-02-12T15:46:36.218910 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761286s001lbl.pdf', 'application_number': 761286, 'submission_type': 'SUPPL ', 'submission_number': 1} |
80,208 | label may not be the latest approved by F
ng information, please visit https://www.fd
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 htt... | custom-source | 2025-02-12T15:46:36.894980 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206910Orig1s019lbl.pdf', 'application_number': 206910, 'submission_type': 'SUPPL ', 'submission_number': 19} |
80,207 |
... | custom-source | 2025-02-12T15:46:36.951909 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208712s003lbl.pdf', 'application_number': 208712, 'submission_type': 'SUPPL ', 'submission_number': 3} |
80,206 |
... | custom-source | 2025-02-12T15:46:37.080059 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021426s043lbl.pdf', 'application_number': 21426, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,210 |
... | custom-source | 2025-02-12T15:46:37.685342 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761074s030lbl.pdf', 'application_number': 761074, 'submission_type': 'SUPPL ', 'submission_number': 30} |
80,212 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SUNLENCA safely and effectively. See full prescribing
information for SUNLENCA.
SUNLENCAยฎ (lenacapavir) tablets, for oral use
SUNLENCAยฎ (lenacapavir) injection, for subcutaneous use
Initial U.S. Approval... | custom-source | 2025-02-12T15:46:38.334215 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215974s009lbl.pdf', 'application_number': 215974, 'submission_type': 'SUPPL ', 'submission_number': 9} |
80,213 |
... | custom-source | 2025-02-12T15:46:39.697670 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208716s017lbl.pdf', 'application_number': 208716, 'submission_type': 'SUPPL ', 'submission_number': 17} |
80,220 |
... | custom-source | 2025-02-12T15:46:39.829010 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205054s007lbl.pdf', 'application_number': 205054, 'submission_type': 'SUPPL ', 'submission_number': 7} |
80,219 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LEQEMBIยฎ safely and effectively. See full prescribing information for
LEQEMBIยฎ.
LEQEMBIยฎ (lecanemab-irmb) injection, for intravenous use
Initial U.S. Approval: 2023
WARNING: AMYLOID RELATED ... | custom-source | 2025-02-12T15:46:40.033668 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761269s008lbl.pdf', 'application_number': 761269, 'submission_type': 'SUPPL ', 'submission_number': 8} |
80,211 |
... | custom-source | 2025-02-12T15:46:40.225925 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761091s033lbl.pdf', 'application_number': 761091, 'submission_type': 'SUPPL ', 'submission_number': 33} |
80,225 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
REVUFORJ safely and effectively. See full prescribing information
for REVUFORJ.
REVUFORJ (revumenib) tablets, for oral use
Initial U.S. Approval: 2024
WARNING: DIFFERENTIATION SYNDROME
S... | custom-source | 2025-02-12T15:46:42.480813 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218944s000lbl.pdf', 'application_number': 218944, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,226 | 1
KENALOG๏-40 INJECTION
KENALOG๏-80 INJECTION
(triamcinolone acetonide injectable suspension, USP)
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
For Intramuscular or Intra-articular Use Only
NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL,
OR INTRATHECAL USE
DESCRIPTION
KENALOG๏-40 Injection and KENALOG๏-80... | custom-source | 2025-02-12T15:46:42.574302 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/014901Orig1s055lbl.pdf', 'application_number': 14901, 'submission_type': 'SUPPL ', 'submission_number': 55} |
80,230 |
... | custom-source | 2025-02-12T15:46:46.250600 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761340s003lbl.pdf', 'application_number': 761340, 'submission_type': 'SUPPL ', 'submission_number': 3} |
80,223 |
NDA/BLA Multi-Disciplinary Review and Evaluation
NDA 209092/S-018 (ribociclib) and NDA 209935/S-027 (ribociclib+letrozole copack)
2
Version date: August 2023
Disclaimer: In this document, the sections labeled as โDataโ and โThe Applicantโs Positionโ are completed by
the Applicant and do not necessarily refl... | custom-source | 2025-02-12T15:46:47.097670 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/209092s018,209935s027MultidisciplineR.pdf', 'application_number': 209092, 'submission_type': 'SUPPL ', 'submission_number': 18} |
80,224 |
NDA/BLA Multi-Disciplinary Review and Evaluation
NDA 209092/S-018 (ribociclib) and NDA 209935/S-027 (ribociclib+letrozole copack)
2
Version date: August 2023
Disclaimer: In this document, the sections labeled as โDataโ and โThe Applicantโs Positionโ are completed by
the Applicant and do not necessarily refl... | custom-source | 2025-02-12T15:46:47.277655 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/209092s018,209935s027MultidisciplineR.pdf', 'application_number': 209935, 'submission_type': 'SUPPL ', 'submission_number': 27} |
80,228 |
... | custom-source | 2025-02-12T15:46:47.972511 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125261s166,761044s014lbl.pdf', 'application_number': 125261, 'submission_type': 'SUPPL ', 'submission_number': 166} |
80,247 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FLUDARABINE PHOSPHATE INJECTION safely and effectively. See
full prescribing information for FLUDARABINE PHOSPHATE
INJECTION.
FLUDARABINE PHOSPHATE injection, for intravenous use
Initial U.S. Approval: 1991 ... | custom-source | 2025-02-12T15:46:47.988783 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022137s015lbl.pdf', 'application_number': 22137, 'submission_type': 'SUPPL ', 'submission_number': 15} |
80,237 | Vial & Carton Label โ Pemetrexed Injection 100mg/10mL (10mg/mL)
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Vial & Carton Label - Pemetrexed Injection 500 mg/50 mL (10 mg/mL)
This label may not be the latest approved by FDA.
... | custom-source | 2025-02-12T15:46:48.519044 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215179Orig1s002lbl.pdf', 'application_number': 215179, 'submission_type': 'SUPPL ', 'submission_number': 2} |
80,248 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
BELEODAQ safely and effectively. See full prescribing information for
BELEODAQ.
BELEODAQยฎ (belinostat) for injection, for intravenous use
Initial U.S. Approval: 2014
---------------------------RECENT MAJOR CHAN... | custom-source | 2025-02-12T15:46:48.941218 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206256Orig1s006lbl.pdf', 'application_number': 206256, 'submission_type': 'SUPPL ', 'submission_number': 6} |
80,235 | ยฎ
Cetirizine HCl
orally disintegrating tablets
10 mg/antihistamine
0
00000 00000
0
Active ingredient made in Switzerland
Distributed by: JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA
ยฉJ&JCI XXXX Pat. www.jjcipats.com
00000000/000-00-00000.00
www.zyrtec.com
DISSOLVE... | custom-source | 2025-02-12T15:46:49.065170 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022578Orig1s014lbl.pdf', 'application_number': 22578, 'submission_type': 'SUPPL ', 'submission_number': 14} |
80,249 | 1
(Rifabutin) Capsules, USP
DESCRIPTION
MYCOBUTIN Capsules for oral administration contain 150 mg of the rifamycin
antimycobacterial agent rifabutin, USP, per capsule, along with the inactive ingredients,
microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate,
titanium dioxid... | custom-source | 2025-02-12T15:46:49.097462 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050689s027lbl.pdf', 'application_number': 50689, 'submission_type': 'SUPPL ', 'submission_number': 27} |
80,250 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
BIMZELX safely and effectively. See full prescribing information for
BIMZELX.
BIMZELXยฎ (bimekizumab-bkzx) injection, for subcutaneous use
Initial U.S. Approval: 2023
--------------------------RECENT MAJOR C... | custom-source | 2025-02-12T15:46:49.430678 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s010lbl.pdf', 'application_number': 761151, 'submission_type': 'SUPPL ', 'submission_number': 10} |
80,251 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
EPINEPHRINE INJECTION safely and effectively. See full prescribing
information for EPINEPHRINE INJECTION.
EPINEPHRINE injection, for intramuscular or subcutaneous use
Initial U.S. Approval: 1939
-------... | custom-source | 2025-02-12T15:46:49.621792 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020800s052lbl.pdf', 'application_number': 20800, 'submission_type': 'SUPPL ', 'submission_number': 52} |
80,253 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PAXLOVID safely and effectively. See full prescribing information for
PAXLOVID.
PAXLOVIDโข (nirmatrelvir tablets; ritonavir tablets), co-packaged for
oral use
Initial U.S. Approval: 2023
WARNING: SIG... | custom-source | 2025-02-12T15:46:50.063471 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217188s009lbl.pdf', 'application_number': 217188, 'submission_type': 'SUPPL ', 'submission_number': 9} |
80,260 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZOSYN
safely and effectively. See full prescribing information for ZOSYN.
ZOSYNยฎ (piperacillin and tazobactam) injection, for intravenous use
Initial U.S. approval: 1993
-------------------------- INDICATIONS ... | custom-source | 2025-02-12T15:46:50.354206 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050750Orig1s054lbl.pdf', 'application_number': 50750, 'submission_type': 'SUPPL ', 'submission_number': 54} |
80,261 |
CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:
761416Orig1s000
LABELING
FULL PRESCRIBING INFORMATION
WARNING: EMBRYO-FETAL TOXICITY
Embryo-Fetal Toxicity: Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm.
Advise patients of the risk and need for effective contraceptio... | custom-source | 2025-02-12T15:46:50.390605 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761416Orig1s000Lbl.pdf', 'application_number': 761416, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,252 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
QSYMIAยฎ safely and effectively. See full prescribing information for
QSYMIA.
QSYMIA (phentermine and topiramate extended-release capsules), for
oral use, CIV
Initial U.S. Approval: 2012
-------------------... | custom-source | 2025-02-12T15:46:51.056834 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s026lbl.pdf', 'application_number': 22580, 'submission_type': 'SUPPL ', 'submission_number': 26} |
80,269 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LENVIMA safely and effectively. See full prescribing information for
LENVIMA.
LENVIMAยฎ (lenvatinib) capsules, for oral use
Initial U.S. Approval: 2015
----------------------------INDICATIONS AND USAGE---------... | custom-source | 2025-02-12T15:46:52.211645 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206947s032lbl.pdf', 'application_number': 206947, 'submission_type': 'SUPPL ', 'submission_number': 32} |
80,262 |
... | custom-source | 2025-02-12T15:46:52.383950 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125522s044lbl.pdf', 'application_number': 125522, 'submission_type': 'SUPPL ', 'submission_number': 44} |
80,274 | Reference ID: 5483060
Reference ID: 5483060
Reference ID: 5483060
Reference ID: 5483060
Reference ID: 5483060
Reference ID: 5483060
Reference ID: 5483060
Reference ID: 5483060
212153
Reference ID: 5483060
| custom-source | 2025-02-12T15:46:53.988079 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022360Orig1s018lbl.pdf', 'application_number': 22360, 'submission_type': 'SUPPL ', 'submission_number': 18} |
80,281 | PERCODANยฎ
(Oxycodone and Aspirin Tablets, USP)
CII
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF PERCODAN
Addiction, Abuse, and Misuse
Because the use of PERCODAN exposes patients and other users to the risks of opioid addiction,
abuse, and misuse, which can lead to overdose and death, assess each patie... | custom-source | 2025-02-12T15:46:56.093374 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/007337s057lbl.pdf', 'application_number': 7337, 'submission_type': 'SUPPL ', 'submission_number': 57} |
80,288 |
Mefenamic Acid Capsules, USP 250 mg
Rx only
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
Cardiovascular Thrombotic Events
โข Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increas... | custom-source | 2025-02-12T15:46:56.543549 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/015034s046lbl.pdf', 'application_number': 15034, 'submission_type': 'SUPPL ', 'submission_number': 46} |
80,286 |
... | custom-source | 2025-02-12T15:46:57.238872 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011483s037lbl.pdf', 'application_number': 11483, 'submission_type': 'SUPPL ', 'submission_number': 37} |
80,263 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
KEYTRUDA safely and effectively. See full prescribing
information for KEYTRUDA.
KEYTRUDAยฎ (pembrolizumab) injection, for intravenous use
Initial U.S. Approval: 2014
--------------------------- RECENT MAJOR... | custom-source | 2025-02-12T15:46:58.199981 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125514s164lbl.pdf', 'application_number': 125514, 'submission_type': 'SUPPL ', 'submission_number': 164} |
80,290 |
... | custom-source | 2025-02-12T15:46:58.214404 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581s117,018164s067,020067s026lbl.pdf', 'application_number': 17581, 'submission_type': 'SUPPL ', 'submission_number': 117} |
80,292 |
... | custom-source | 2025-02-12T15:46:58.311755 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581s117,018164s067,020067s026lbl.pdf', 'application_number': 18164, 'submission_type': 'SUPPL ', 'submission_number': 67} |
80,294 |
... | custom-source | 2025-02-12T15:46:58.636884 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581s117,018164s067,020067s026lbl.pdf', 'application_number': 20067, 'submission_type': 'SUPPL ', 'submission_number': 26} |
80,296 |
... | custom-source | 2025-02-12T15:46:59.068797 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017814s045lbl.pdf', 'application_number': 17814, 'submission_type': 'SUPPL ', 'submission_number': 45} |
80,321 |
... | custom-source | 2025-02-12T15:46:59.800091 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018965s028lbl.pdf', 'application_number': 18965, 'submission_type': 'SUPPL ', 'submission_number': 28} |
80,300 |
... | custom-source | 2025-02-12T15:46:59.886646 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018858s049lbl.pdf', 'application_number': 18858, 'submission_type': 'SUPPL ', 'submission_number': 49} |
80,298 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INDOCINยฎ ORAL SUSPENSION safely and effectively. See full
prescribing information for INDOCIN.
INDOCIN (indomethacin) Oral Suspension, for oral use
Initi... | custom-source | 2025-02-12T15:46:59.917545 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018332s043lbl.pdf', 'application_number': 18332, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,323 |
... | custom-source | 2025-02-12T15:47:00.331521 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020353s041lbl.pdf', 'application_number': 20353, 'submission_type': 'SUPPL ', 'submission_number': 41} |
80,329 |
... | custom-source | 2025-02-12T15:47:00.406853 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217202s000lbl.pdf', 'application_number': 217202, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,325 |
... | custom-source | 2025-02-12T15:47:00.960215 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209471s001lbl.pdf', 'application_number': 209471, 'submission_type': 'SUPPL ', 'submission_number': 1} |
80,330 |
... | custom-source | 2025-02-12T15:47:01.313106 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216540s000lbl.pdf', 'application_number': 216540, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,331 |
... | custom-source | 2025-02-12T15:47:01.684435 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020397s029,021447s017lbl.pdf', 'application_number': 20397, 'submission_type': 'SUPPL ', 'submission_number': 29} |
80,327 |
... | custom-source | 2025-02-12T15:47:01.914608 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213426s003lbl.pdf', 'application_number': 213426, 'submission_type': 'SUPPL ', 'submission_number': 3} |
80,332 |
... | custom-source | 2025-02-12T15:47:02.083352 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020397s029,021447s017lbl.pdf', 'application_number': 21447, 'submission_type': 'SUPPL ', 'submission_number': 17} |
80,333 |
... | custom-source | 2025-02-12T15:47:02.333259 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761263s005lbl.pdf', 'application_number': 761263, 'submission_type': 'SUPPL ', 'submission_number': 5} |
80,354 |
... | custom-source | 2025-02-12T15:47:03.156297 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212862s008lbl.pdf', 'application_number': 212862, 'submission_type': 'SUPPL ', 'submission_number': 8} |
80,356 |
... | custom-source | 2025-02-12T15:47:03.694569 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761115s058lbl.pdf', 'application_number': 761115, 'submission_type': 'SUPPL ', 'submission_number': 58} |
80,342 |
... | custom-source | 2025-02-12T15:47:03.812942 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204370s012lbl.pdf', 'application_number': 204370, 'submission_type': 'SUPPL ', 'submission_number': 12} |
80,357 |
... | custom-source | 2025-02-12T15:47:04.081674 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761170s007lbl.pdf', 'application_number': 761170, 'submission_type': 'SUPPL ', 'submission_number': 7} |
80,358 |
... | custom-source | 2025-02-12T15:47:04.667817 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219097s000lbl.pdf', 'application_number': 219097, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,362 |
0
0
II
)-l___
H 2 N ............... 0 ~
0 _,,
NH 2
H 3 c' ~
CH 3
ASPIRIN
HO
.,,,.:::;O
H 3 C.........._..,O=c
II
I
0
.,,,.:::;
EQUAGESICยฎ CIV
(meprobamate and aspirin tablets)
Rx... | custom-source | 2025-02-12T15:47:04.919016 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011702s041lbl.pdf', 'application_number': 11702, 'submission_type': 'SUPPL ', 'submission_number': 41} |
80,359 |
... | custom-source | 2025-02-12T15:47:05.370324 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215320s001lbl.pdf', 'application_number': 215320, 'submission_type': 'SUPPL ', 'submission_number': 1} |
80,360 |
... | custom-source | 2025-02-12T15:47:05.389558 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217927s002lbl.pdf', 'application_number': 217927, 'submission_type': 'SUPPL ', 'submission_number': 2} |
80,363 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INDOCINยฎ CAPSULES safely and effectively. See full prescribing
information for INDOCIN.
INDOCIN (indomethacin) Capsules, for oral use
Initial U.S. Approval: 1965
WARNING: RISK OF SERIOUS CARDIOVASCULAR ... | custom-source | 2025-02-12T15:47:05.809030 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016059s102lbl.pdf', 'application_number': 16059, 'submission_type': 'SUPPL ', 'submission_number': 102} |
80,365 |
... | custom-source | 2025-02-12T15:47:05.821810 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017604s054lbl.pdf', 'application_number': 17604, 'submission_type': 'SUPPL ', 'submission_number': 54} |
80,367 |
... | custom-source | 2025-02-12T15:47:06.175470 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018147s053lbl.pdf', 'application_number': 18147, 'submission_type': 'SUPPL ', 'submission_number': 53} |
80,369 |
... | custom-source | 2025-02-12T15:47:06.416425 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018185s059lbl.pdf', 'application_number': 18185, 'submission_type': 'SUPPL ', 'submission_number': 59} |
80,371 |
Indomethacin Capsules, USP
25 mg
Rx only
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
โข
Nonsteroidal an... | custom-source | 2025-02-12T15:47:07.174448 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018829s025lbl.pdf', 'application_number': 18829, 'submission_type': 'SUPPL ', 'submission_number': 25} |
80,373 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SOLARAZEยฎ ... | custom-source | 2025-02-12T15:47:07.291098 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021005s025lbl.pdf', 'application_number': 21005, 'submission_type': 'SUPPL ', 'submission_number': 25} |
80,374 |
... | custom-source | 2025-02-12T15:47:08.170248 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018841s036lbl.pdf', 'application_number': 18841, 'submission_type': 'SUPPL ', 'submission_number': 36} |
80,376 |
... | custom-source | 2025-02-12T15:47:08.399449 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018851s029lbl.pdf', 'application_number': 18851, 'submission_type': 'SUPPL ', 'submission_number': 29} |
80,380 |
... | custom-source | 2025-02-12T15:47:08.815880 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020938s030lbl.pdf', 'application_number': 20938, 'submission_type': 'SUPPL ', 'submission_number': 30} |
80,378 |
... | custom-source | 2025-02-12T15:47:08.848536 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020776s013lbl.pdf', 'application_number': 20776, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,384 |
... | custom-source | 2025-02-12T15:47:10.287757 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021234s024lbl.pdf', 'application_number': 21234, 'submission_type': 'SUPPL ', 'submission_number': 24} |
80,382 |
... | custom-source | 2025-02-12T15:47:10.588875 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020998s058lbl.pdf', 'application_number': 20998, 'submission_type': 'SUPPL ', 'submission_number': 58} |
80,386 |
... | custom-source | 2025-02-12T15:47:10.626767 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021530s020lbl.pdf', 'application_number': 21530, 'submission_type': 'SUPPL ', 'submission_number': 20} |
80,388 |
... | custom-source | 2025-02-12T15:47:10.722865 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022202s016lbl.pdf', 'application_number': 22202, 'submission_type': 'SUPPL ', 'submission_number': 16} |
80,391 |
... | custom-source | 2025-02-12T15:47:11.532270 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022382s022lbl.pdf', 'application_number': 22382, 'submission_type': 'SUPPL ', 'submission_number': 22} |
80,393 |
... | custom-source | 2025-02-12T15:47:11.858323 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204592s014lbl.pdf', 'application_number': 204592, 'submission_type': 'SUPPL ', 'submission_number': 14} |
80,390 |
... | custom-source | 2025-02-12T15:47:12.085026 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022348s027lbl.pdf', 'application_number': 22348, 'submission_type': 'SUPPL ', 'submission_number': 27} |
80,395 |
... | custom-source | 2025-02-12T15:47:12.244818 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204623s013lbl.pdf', 'application_number': 204623, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,397 |
... | custom-source | 2025-02-12T15:47:12.617129 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206976s016lbl.pdf', 'application_number': 206976, 'submission_type': 'SUPPL ', 'submission_number': 16} |
80,399 |
... | custom-source | 2025-02-12T15:47:12.966834 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207233s005lbl.pdf', 'application_number': 207233, 'submission_type': 'SUPPL ', 'submission_number': 5} |
80,402 | WARNING: RISK OF SERIOUS CARDIOVASCULAR
AND GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed warning
Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious cardiovascular thrombotic events, including myocardial
infarction and stroke, which can be fatal. This risk ... | custom-source | 2025-02-12T15:47:13.156200 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022165s016lbl.pdf', 'application_number': 22165, 'submission_type': 'SUPPL ', 'submission_number': 16} |
80,401 |
... | custom-source | 2025-02-12T15:47:13.898080 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211988s018lbl.pdf', 'application_number': 211988, 'submission_type': 'SUPPL ', 'submission_number': 18} |
80,404 |
... | custom-source | 2025-02-12T15:47:13.949678 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212157s003lbl.pdf', 'application_number': 212157, 'submission_type': 'SUPPL ', 'submission_number': 3} |
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