id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
79,862 |
__________________
_______________
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use EYLEA
safely and effectively. See full prescribing information for EYLEA.
EYLEA® (aflibercept) injection, for intravitreal use
Initial U.S. Approval: 2011
____... | custom-source | 2025-02-12T15:45:37.406077 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf', 'application_number': 125387, 'submission_type': 'SUPPL ', 'submission_number': 87} |
79,863 |
CH3COO
;
CH30
OH '
NH
;-"\
N-CHs
CH=N-N\._/
RIFADIN®
(rifampin capsules USP)
and
RIFADIN® IV
(rifampin for injection USP)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of RIFADIN
(rifampin caps... | custom-source | 2025-02-12T15:45:37.583093 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050420s092,050627s037lbl.pdf', 'application_number': 50420, 'submission_type': 'SUPPL ', 'submission_number': 92} |
79,864 |
CH3COO
;
CH30
OH '
NH
;-"\
N-CHs
CH=N-N\._/
RIFADIN®
(rifampin capsules USP)
and
RIFADIN® IV
(rifampin for injection USP)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of RIFADIN
(rifampin caps... | custom-source | 2025-02-12T15:45:38.028032 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050420s092,050627s037lbl.pdf', 'application_number': 50627, 'submission_type': 'SUPPL ', 'submission_number': 37} |
79,866 |
RIFATER®
(rifampin, isoniazid and pyrazinamide USP)
Tablets
WARNING
Severe and sometimes fatal hepatitis associated with isoniazid, a component of RIFATER,
therapy may occur and may develop even after many months of treatment. The risk of... | custom-source | 2025-02-12T15:45:38.223570 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050705s026lbl.pdf', 'application_number': 50705, 'submission_type': 'SUPPL ', 'submission_number': 26} |
79,877 |
... | custom-source | 2025-02-12T15:45:38.711712 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s019lbl.pdf', 'application_number': 761049, 'submission_type': 'SUPPL ', 'submission_number': 19} |
79,875 |
... | custom-source | 2025-02-12T15:45:39.890233 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761364s000lbl.pdf', 'application_number': 761364, 'submission_type': 'ORIG ', 'submission_number': 1} |
79,887 | NDA 050795/S-036
Page 3
U.S. Food & Drug Administration
Silver Spring, MD 20993
www.fda.gov
Container Label:
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
David
Lewis
Digitally signed by David Lewis
Date: 7/15/2024 12:53:09PM
GUI... | custom-source | 2025-02-12T15:45:40.057286 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050795Orig1s036lbl.pdf', 'application_number': 50795, 'submission_type': 'SUPPL ', 'submission_number': 36} |
79,879 |
____________________... | custom-source | 2025-02-12T15:45:40.067346 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205832s028lbl.pdf', 'application_number': 205832, 'submission_type': 'SUPPL ', 'submission_number': 28} |
79,880 |
... | custom-source | 2025-02-12T15:45:40.082033 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s009lbl.pdf', 'application_number': 761151, 'submission_type': 'SUPPL ', 'submission_number': 9} |
79,888 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NYMALIZE® safely and effectively. See full prescribing information for
NYMALIZE.
NYMALIZE (nimodipine) oral solution
Initial U.S. Approval: 1988
------------------------------INDICATIONS AND USE---------------... | custom-source | 2025-02-12T15:45:40.273191 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203340Orig1s019lbl.pdf', 'application_number': 203340, 'submission_type': 'SUPPL ', 'submission_number': 19} |
79,890 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
SUN AM
MON AM
TUE AM
WED AM
THU AM
FRI AM
SAT AM
SUN PM
MON PM
TUE PM
WED PM
THU PM
FRI PM
SAT PM
This label may not be the latest approved by FDA.
For current ... | custom-source | 2025-02-12T15:45:40.369146 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213388Orig1s005lbl.pdf', 'application_number': 213388, 'submission_type': 'SUPPL ', 'submission_number': 5} |
79,892 | 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 | 2025-02-12T15:45:40.524200 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s020, 209935Orig1s028lbl.pdf', 'application_number': 209935, 'submission_type': 'SUPPL ', 'submission_number': 28} |
79,891 | 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 | 2025-02-12T15:45:40.549563 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s020, 209935Orig1s028lbl.pdf', 'application_number': 209092, 'submission_type': 'SUPPL ', 'submission_number': 20} |
79,889 | Lot
Exp
Lot
16641023
Dotarem
® 2.5 mmol per 5 mL
Dotarem
®
(Gadoterate Meglumine) Injection
2.5 mmol per 5 mL
(0.5 mmol per mL) - Sterile Solution
For Intravenous Administration
Single Dose Vial - Discard Unused Portion
Dispense the Medication Guide provided separately to each patient
NDC 67684-2001-0
Mfd. for and dist... | custom-source | 2025-02-12T15:45:40.559290 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204781Orig1s014lbl.pdf', 'application_number': 204781, 'submission_type': 'SUPPL ', 'submission_number': 14} |
79,895 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CIPRO
IV safely and effectively. See full prescribing information for CIPRO IV.
CIPRO® IV (ciprofloxacin) injection, for intravenous use
Initial U.S. Approval: 1987
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING
... | custom-source | 2025-02-12T15:45:41.152510 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019847Orig1s064correctedlbl.pdf', 'application_number': 19847, 'submission_type': 'SUPPL ', 'submission_number': 64} |
79,898 |
... | custom-source | 2025-02-12T15:45:42.175555 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022350s026lbl.pdf', 'application_number': 22350, 'submission_type': 'SUPPL ', 'submission_number': 26} |
79,912 |
... | custom-source | 2025-02-12T15:45:42.700160 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761369s000lbl.pdf', 'application_number': 761369, 'submission_type': 'ORIG ', 'submission_number': 1} |
79,896 |
... | custom-source | 2025-02-12T15:45:42.730869 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200678s028lbl.pdf', 'application_number': 200678, 'submission_type': 'SUPPL ', 'submission_number': 28} |
79,913 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VYLOY
safely and effectively. See full prescribing information for VYLOY.
VYLOY® (zolbetuximab-clzb) for injection, for intravenous use
Initial U.S. Approval: 2024
--------------------------- INDICATIONS AN... | custom-source | 2025-02-12T15:45:42.952873 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761365s000lbl.pdf', 'application_number': 761365, 'submission_type': 'ORIG ', 'submission_number': 1} |
79,916 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZOLADEX safely and effectively.
See full prescribing information for ZOLADEX.
ZOLADEX® (goserelin implant) 10.8 mg
Initial U.S. Approval: 1996
---------------------------INDICATIONS AND USAGE----------... | custom-source | 2025-02-12T15:45:43.119044 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020578s044lbl.pdf', 'application_number': 20578, 'submission_type': 'SUPPL ', 'submission_number': 44} |
79,920 |
... | custom-source | 2025-02-12T15:45:45.260710 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.pdf', 'application_number': 103000, 'submission_type': 'SUPPL ', 'submission_number': 5323} |
79,917 |
... | custom-source | 2025-02-12T15:45:45.334169 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.pdf', 'application_number': 103000, 'submission_type': 'SUPPL ', 'submission_number': 5316} |
79,921 |
... | custom-source | 2025-02-12T15:45:45.486015 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.pdf', 'application_number': 103000, 'submission_type': 'SUPPL ', 'submission_number': 5319} |
79,919 |
... | custom-source | 2025-02-12T15:45:45.490701 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.pdf', 'application_number': 103000, 'submission_type': 'SUPPL ', 'submission_number': 5331} |
79,935 |
... | custom-source | 2025-02-12T15:45:56.543942 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf', 'application_number': 217806, 'submission_type': 'SUPPL ', 'submission_number': 5} |
79,934 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FRAGMIN safely and effectively. See full prescribing information for
FRAGMIN.
FRAGMIN® (dalteparin sodium) injection, USP, for subcutaneous use
Initial U.S. Approval: 1994
WARNING: SPINAL/EPIDURAL HEMATOMAS ... | custom-source | 2025-02-12T15:45:56.578966 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020287Orig1s080lbl.pdf', 'application_number': 20287, 'submission_type': 'SUPPL ', 'submission_number': 80} |
79,937 |
... | custom-source | 2025-02-12T15:45:56.750663 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf', 'application_number': 217806, 'submission_type': 'SUPPL ', 'submission_number': 11} |
79,936 |
... | custom-source | 2025-02-12T15:45:56.781734 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf', 'application_number': 217806, 'submission_type': 'SUPPL ', 'submission_number': 6} |
79,941 |
... | custom-source | 2025-02-12T15:45:58.722449 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214621s006lbl.pdf', 'application_number': 214621, 'submission_type': 'SUPPL ', 'submission_number': 6} |
79,938 |
... | custom-source | 2025-02-12T15:45:59.107799 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf', 'application_number': 217806, 'submission_type': 'SUPPL ', 'submission_number': 19} |
79,942 |
... | custom-source | 2025-02-12T15:45:59.388071 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216962s000lbl.pdf', 'application_number': 216962, 'submission_type': 'ORIG ', 'submission_number': 1} |
79,943 |
... | custom-source | 2025-02-12T15:45:59.496071 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214755s006lbl.pdf', 'application_number': 214755, 'submission_type': 'SUPPL ', 'submission_number': 6} |
79,945 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FENSOLVI® safely and effectively. See full prescribing information for
FENSOLVI.
FENSOLVI
(leuprolide
acetate)
for
injectable
suspension,
for
subcutaneous use
Initial U.S. Approval: 1985
--------... | custom-source | 2025-02-12T15:45:59.603361 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213150s004lbl.pdf', 'application_number': 213150, 'submission_type': 'SUPPL ', 'submission_number': 4} |
79,950 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
USTEKINUMAB-AEKN safely and effectively. See full prescribing
information for USTEKINUMAB-AEKN.
USTEKINUMAB-AEKN injection, for subcutaneous or intravenous use
Initial U.S. Approval: 2024
Ustekinumab-aekn ... | custom-source | 2025-02-12T15:46:01.439019 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761343s001s003lbl.pdf', 'application_number': 761343, 'submission_type': 'SUPPL ', 'submission_number': 3} |
79,949 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
USTEKINUMAB-AEKN safely and effectively. See full prescribing
information for USTEKINUMAB-AEKN.
USTEKINUMAB-AEKN injection, for subcutaneous or intravenous use
Initial U.S. Approval: 2024
Ustekinumab-aekn ... | custom-source | 2025-02-12T15:46:01.481282 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761343s001s003lbl.pdf', 'application_number': 761343, 'submission_type': 'SUPPL ', 'submission_number': 1} |
79,947 |
... | custom-source | 2025-02-12T15:46:01.520354 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761343s002lbl.pdf', 'application_number': 761343, 'submission_type': 'SUPPL ', 'submission_number': 2} |
79,952 |
... | custom-source | 2025-02-12T15:46:01.724900 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s005s006s011s015s019lbl.pdf', 'application_number': 217806, 'submission_type': 'SUPPL ', 'submission_number': 15} |
79,953 |
... | custom-source | 2025-02-12T15:46:02.125683 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216593s001lbl.pdf', 'application_number': 216593, 'submission_type': 'SUPPL ', 'submission_number': 1} |
79,957 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
BIKTARVY safely and effectively. See full prescribing information
for BIKTARVY.
BIKTARVY® (bictegravir, emtricitabine, and tenofovir alafenamide)
tablets, for oral use
Initial U.S. Approval: 2018
WARNING: PO... | custom-source | 2025-02-12T15:46:02.446138 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251Orig1s020lbl.pdf', 'application_number': 210251, 'submission_type': 'SUPPL ', 'submission_number': 20} |
79,961 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use ORLADEYO® safely and effectively. See full prescribing
information for ORLAD... | custom-source | 2025-02-12T15:46:02.649365 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214094s003lbl.pdf', 'application_number': 214094, 'submission_type': 'SUPPL ', 'submission_number': 3} |
79,958 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PRECEDEX safely and effectively. See full prescribing information for
PRECEDEX.
PRECEDEXTM (dexmedetomidine hydrochloride) injection, for
intravenous use
PRECEDEXTM (dexmedetomidine hydrochloride) in sodium ... | custom-source | 2025-02-12T15:46:03.031716 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021038Orig1s055lbl.pdf', 'application_number': 21038, 'submission_type': 'SUPPL ', 'submission_number': 55} |
79,962 |
... | custom-source | 2025-02-12T15:46:03.214578 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125553s038lbl.pdf', 'application_number': 125553, 'submission_type': 'SUPPL ', 'submission_number': 38} |
79,976 |
HI... | custom-source | 2025-02-12T15:46:03.960819 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205919s007lbl.pdf', 'application_number': 205919, 'submission_type': 'SUPPL ', 'submission_number': 7} |
79,970 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
MEKINIST safely and effectively. See full prescribing information for
MEKINIST.
MEKINIST® (trametinib) tablets, for oral use
MEKINIST® (trametinib) for oral solution
Initial U.S. Approval: 2013
---... | custom-source | 2025-02-12T15:46:04.449255 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s027,217513s007lbl.pdf', 'application_number': 217513, 'submission_type': 'SUPPL ', 'submission_number': 7} |
79,977 |
... | custom-source | 2025-02-12T15:46:05.137651 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212479s002s003lbl.pdf', 'application_number': 212479, 'submission_type': 'SUPPL ', 'submission_number': 2} |
79,978 |
... | custom-source | 2025-02-12T15:46:05.335385 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212479s002s003lbl.pdf', 'application_number': 212479, 'submission_type': 'SUPPL ', 'submission_number': 3} |
79,969 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
MEKINIST safely and effectively. See full prescribing information for
MEKINIST.
MEKINIST® (trametinib) tablets, for oral use
MEKINIST® (trametinib) for oral solution
Initial U.S. Approval: 2013
---... | custom-source | 2025-02-12T15:46:05.424316 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s027,217513s007lbl.pdf', 'application_number': 204114, 'submission_type': 'SUPPL ', 'submission_number': 27} |
79,981 |
... | custom-source | 2025-02-12T15:46:05.688668 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213972s000lbl.pdf', 'application_number': 213972, 'submission_type': 'ORIG ', 'submission_number': 1} |
79,986 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
... | custom-source | 2025-02-12T15:46:06.224654 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761169s011lbl.pdf', 'application_number': 761169, 'submission_type': 'SUPPL ', 'submission_number': 11} |
79,979 |
... | custom-source | 2025-02-12T15:46:06.629449 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218711s000lbl.pdf', 'application_number': 218711, 'submission_type': 'ORIG ', 'submission_number': 1} |
79,989 |
CH
CH
OH COO
HO
OH
~
I
N1'1S~-
0
OH
NHAc~OH
H
OH
H
HO
HO
H
0
~-
OH
OH
(I)
(7)
( 3)
,.,
(SJ
LIQUAEMIN® SODIUM
(heparin sodium injection, USP)... | custom-source | 2025-02-12T15:46:07.058906 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/000552s026lbl.pdf', 'application_number': 552, 'submission_type': 'SUPPL ', 'submission_number': 26} |
79,984 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BKEMV
safely and effectively. See full prescribing information for BKEMV.
BKEMV™ (eculizumab-aeeb) injection, for intravenous use
Initial U.S. Approval: 2024
BKEMV (eculizumab-aeeb) is bi... | custom-source | 2025-02-12T15:46:07.484785 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761333s001lbl.pdf', 'application_number': 761333, 'submission_type': 'SUPPL ', 'submission_number': 1} |
79,987 |
... | custom-source | 2025-02-12T15:46:07.532901 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s001lbl.pdf', 'application_number': 761362, 'submission_type': 'SUPPL ', 'submission_number': 1} |
79,990 |
NHSO3
(1)
(2)
coo-
H
HO
(3)
OH
OH
(4)
oOH
NHC... | custom-source | 2025-02-12T15:46:07.689027 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017007s040lbl.pdf', 'application_number': 17007, 'submission_type': 'SUPPL ', 'submission_number': 40} |
79,991 |
... | custom-source | 2025-02-12T15:46:08.374539 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017029s178lbl.pdf', 'application_number': 17029, 'submission_type': 'SUPPL ', 'submission_number': 178} |
79,993 |
C?4:zOSO-
:-
•
...,o,-~yoi<
~°" 0
,oo- . •
OH
t,c)
011
•
HO
OH
osoj
OM
~
I
(1)
(2)
(J)
OH
(4)
(5)
Heparin Sodium Injection, USP
DESCRIPTlON
Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, ca... | custom-source | 2025-02-12T15:46:08.518483 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017064s060lbl.pdf', 'application_number': 17064, 'submission_type': 'SUPPL ', 'submission_number': 60} |
79,992 |
... | custom-source | 2025-02-12T15:46:08.692015 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017037s201lbl.pdf', 'application_number': 17037, 'submission_type': 'SUPPL ', 'submission_number': 201} |
79,994 |
... | custom-source | 2025-02-12T15:46:08.796903 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017651s078lbl.pdf', 'application_number': 17651, 'submission_type': 'SUPPL ', 'submission_number': 78} |
79,996 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
HEPARIN SODIUM INJECTION safely and effectively. See full
prescribing information for HEPARIN SODIUM INJECTION.
HEPARIN SODIUM INJECTION, for intravenous or subcutaneous use
Initial U.S. Approval: 1939
... | custom-source | 2025-02-12T15:46:09.202350 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201370s021lbl.pdf', 'application_number': 201370, 'submission_type': 'SUPPL ', 'submission_number': 21} |
79,995 |
... | custom-source | 2025-02-12T15:46:09.204627 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018916s079lbl.pdf', 'application_number': 18916, 'submission_type': 'SUPPL ', 'submission_number': 79} |
79,997 |
... | custom-source | 2025-02-12T15:46:09.601764 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020287s081lbl.pdf', 'application_number': 20287, 'submission_type': 'SUPPL ', 'submission_number': 81} |
80,002 |
... | custom-source | 2025-02-12T15:46:10.162641 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214665s012lbl.pdf', 'application_number': 214665, 'submission_type': 'SUPPL ', 'submission_number': 12} |
79,998 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
KISQALI safely and effectively. See full prescribing information for
KISQALI.
KISQALI® (ribociclib) tablets, for oral use
Initial U.S. Approval: 2017
----------------------------RECENT MAJOR CHANGES------------... | custom-source | 2025-02-12T15:46:10.303343 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf', 'application_number': 209092, 'submission_type': 'SUPPL ', 'submission_number': 18} |
79,999 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
KISQALI FEMARA CO-PACK safely and effectively. See full
prescribing information for KISQALI FEMARA CO-PACK.
KISQALI® FEMARA® CO-PACK (ribociclib tablets; letrozole tablets),
co-packaged for oral use
Initial U.S... | custom-source | 2025-02-12T15:46:10.724808 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209935Orig1s027lbl.pdf', 'application_number': 209935, 'submission_type': 'SUPPL ', 'submission_number': 27} |
80,018 |
--------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
-------------------------------... | custom-source | 2025-02-12T15:46:10.758588 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022051Orig1s023, 205434Orig1s016Lbl.pdf', 'application_number': 205434, 'submission_type': 'SUPPL ', 'submission_number': 16} |
80,017 |
--------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
-------------------------------... | custom-source | 2025-02-12T15:46:10.839870 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022051Orig1s023, 205434Orig1s016Lbl.pdf', 'application_number': 22051, 'submission_type': 'SUPPL ', 'submission_number': 23} |
80,021 |
SPORANOX®
(itraconazole)
Capsules
BOXED WARNING
Congestive Heart Failure, Cardiac Effects and Drug Interactions
Congestive Heart Failure and Cardiac Effects:
• SPORANOX® (it... | custom-source | 2025-02-12T15:46:11.480655 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020083s071lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 71} |
80,022 |
SPORANOX®
(itraconazole)
Oral Solution
BOXED WARNING
Congestive Heart Failure, Cardiac Effects and Drug Interactions
Congestive Heart Failure and Cardiac Effects:
• If signs or symptoms of con... | custom-source | 2025-02-12T15:46:12.764299 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020657s044lbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 44} |
80,023 |
... | custom-source | 2025-02-12T15:46:13.344164 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208901s004lbl.pdf', 'application_number': 208901, 'submission_type': 'SUPPL ', 'submission_number': 4} |
80,024 |
... | custom-source | 2025-02-12T15:46:14.335130 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022003s033,205053s017,205596s020,214770s008lbl.pdf', 'application_number': 22003, 'submission_type': 'SUPPL ', 'submission_number': 33} |
80,025 |
... | custom-source | 2025-02-12T15:46:15.283812 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022003s033,205053s017,205596s020,214770s008lbl.pdf', 'application_number': 205053, 'submission_type': 'SUPPL ', 'submission_number': 17} |
80,026 |
... | custom-source | 2025-02-12T15:46:15.581776 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022003s033,205053s017,205596s020,214770s008lbl.pdf', 'application_number': 205596, 'submission_type': 'SUPPL ', 'submission_number': 20} |
80,027 |
... | custom-source | 2025-02-12T15:46:15.911293 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022003s033,205053s017,205596s020,214770s008lbl.pdf', 'application_number': 214770, 'submission_type': 'SUPPL ', 'submission_number': 8} |
80,028 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These ... | custom-source | 2025-02-12T15:46:16.037696 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s012lbl.pdf', 'application_number': 761113, 'submission_type': 'SUPPL ', 'submission_number': 12} |
80,039 |
LIMBITROL®
(chlordiazepoxide)
(amitriptyline HCI)
DS (double strength) TABLETS
TABLETS
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS;
ABUSE, MISUSE, AND ADDICTION; DEPENDENCE AND WITH... | custom-source | 2025-02-12T15:46:16.568284 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016949s043lbl.pdf', 'application_number': 16949, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,029 |
... | custom-source | 2025-02-12T15:46:16.666879 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s011lbl.pdf', 'application_number': 761113, 'submission_type': 'SUPPL ', 'submission_number': 11} |
80,042 |
... | custom-source | 2025-02-12T15:46:17.228817 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016885s033lbl.pdf', 'application_number': 16885, 'submission_type': 'SUPPL ', 'submission_number': 33} |
80,040 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SCEMBLIX safely and effectively. See full prescribing information for
SCEMBLIX.
SCEMBLIX® (asciminib) tablets, for oral use
Initial U.S. Approval: 2021
----------------------------RECENT MAJOR CHANGES----------... | custom-source | 2025-02-12T15:46:17.229490 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf', 'application_number': 215358, 'submission_type': 'SUPPL ', 'submission_number': 8} |
80,044 |
... | custom-source | 2025-02-12T15:46:17.706113 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200153s009s013s014lbl.pdf', 'application_number': 200153, 'submission_type': 'SUPPL ', 'submission_number': 9} |
80,045 |
... | custom-source | 2025-02-12T15:46:18.436104 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200153s009s013s014lbl.pdf', 'application_number': 200153, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,046 |
... | custom-source | 2025-02-12T15:46:18.662174 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200153s009s013s014lbl.pdf', 'application_number': 200153, 'submission_type': 'SUPPL ', 'submission_number': 14} |
80,055 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
BRIUMVI safely and effectively. See full prescribing information for
BRIUMVI.
BRIUMVI® (ublituximab-xiiy) injection, for intravenous use
Initial U.S. Approval: 2022
_____________... | custom-source | 2025-02-12T15:46:18.867174 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761238s011lbl.pdf', 'application_number': 761238, 'submission_type': 'SUPPL ', 'submission_number': 11} |
80,063 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LOQTORZI safely and effectively. See full prescribing information for
LOQTORZI.
LOQTORZI (toripalimab-tpzi) injection, for intravenous use
Initial U.S. Approval: 2023
------------------------RECENT AND MAJOR CH... | custom-source | 2025-02-12T15:46:19.740019 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761240Orig1s002lbl.pdf', 'application_number': 761240, 'submission_type': 'SUPPL ', 'submission_number': 2} |
80,054 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
XYLOCAINE® and XYLOCAINE® WITH EPINEPHRINE safely and
effectively. See full prescribing information for XYLOCAINE® and
XYLOCAINE® WITH EPINEPHRINE.
XYLOCAINE® (lidocaine hydrochloride) injection, for ... | custom-source | 2025-02-12T15:46:19.903333 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/006488Orig1s100lbl.pdf', 'application_number': 6488, 'submission_type': 'SUPPL ', 'submission_number': 100} |
80,057 |
... | custom-source | 2025-02-12T15:46:19.955978 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761112s013lbl.pdf', 'application_number': 761112, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,064 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VICTOZA safely and effectively. See full prescribing information for
VICTOZA.
VICTOZA® (liraglutide) injection, for subcutaneous use
Initial U.S. Approval: 2010
∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙CONTRAI... | custom-source | 2025-02-12T15:46:20.327893 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022341Orig1s043lbl.pdf', 'application_number': 22341, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,100 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NICARDIPINE HYDROCHLORIDE safely and effectively. See full
prescribing information for NICARDIPINE HYDROCHLORIDE.
NICARDIPINE HYDROCHLORIDE injection, for intravenous use
NICARDIPINE HYDROCHLORIDE in Sodium Ch... | custom-source | 2025-02-12T15:46:20.527442 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022276Orig1s025lbl.pdf', 'application_number': 22276, 'submission_type': 'SUPPL ', 'submission_number': 25} |
80,066 |
... | custom-source | 2025-02-12T15:46:20.899251 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022160s016lbl.pdf', 'application_number': 22160, 'submission_type': 'SUPPL ', 'submission_number': 16} |
80,101 |
... | custom-source | 2025-02-12T15:46:21.403821 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208673s014lbl.pdf', 'application_number': 208673, 'submission_type': 'SUPPL ', 'submission_number': 14} |
80,105 |
... | custom-source | 2025-02-12T15:46:22.266723 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022200s035lbl.pdf', 'application_number': 22200, 'submission_type': 'SUPPL ', 'submission_number': 35} |
80,107 |
... | custom-source | 2025-02-12T15:46:22.815547 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209210s024lbl.pdf', 'application_number': 209210, 'submission_type': 'SUPPL ', 'submission_number': 24} |
80,103 |
... | custom-source | 2025-02-12T15:46:23.527123 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206321s019lbl.pdf', 'application_number': 206321, 'submission_type': 'SUPPL ', 'submission_number': 19} |
80,109 |
... | custom-source | 2025-02-12T15:46:24.077061 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021773s049lbl.pdf', 'application_number': 21773, 'submission_type': 'SUPPL ', 'submission_number': 49} |
80,111 |
... | custom-source | 2025-02-12T15:46:24.422566 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208583s024lbl.pdf', 'application_number': 208583, 'submission_type': 'SUPPL ', 'submission_number': 24} |
80,113 |
... | custom-source | 2025-02-12T15:46:26.639517 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208471s009lbl.pdf', 'application_number': 208471, 'submission_type': 'SUPPL ', 'submission_number': 9} |
80,134 |
... | custom-source | 2025-02-12T15:46:27.838152 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s021lbl.pdf', 'application_number': 215256, 'submission_type': 'SUPPL ', 'submission_number': 21} |
80,115 |
... | custom-source | 2025-02-12T15:46:27.997127 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125469s061s062lbl.pdf', 'application_number': 125469, 'submission_type': 'SUPPL ', 'submission_number': 61} |
80,116 |
... | custom-source | 2025-02-12T15:46:28.314125 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125469s061s062lbl.pdf', 'application_number': 125469, 'submission_type': 'SUPPL ', 'submission_number': 62} |
80,136 |
... | custom-source | 2025-02-12T15:46:28.970161 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf', 'application_number': 215866, 'submission_type': 'SUPPL ', 'submission_number': 22} |
80,137 |
... | custom-source | 2025-02-12T15:46:29.268686 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215866s010s015s022lbl.pdf', 'application_number': 215866, 'submission_type': 'SUPPL ', 'submission_number': 15} |
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