id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
80,673 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
BRAFTOVI safely and effectively. See full prescribing information for
BRAFTOVI.
BRAFTOVI® (encorafenib) capsules, for oral use
Initial U.S. Approval: 201... | custom-source | 2025-02-12T15:47:58.944175 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s017lbl.pdf', 'application_number': 210496, 'submission_type': 'SUPPL ', 'submission_number': 17} |
80,677 |
... | custom-source | 2025-02-12T15:47:58.960820 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020367s122lbl.pdf', 'application_number': 20367, 'submission_type': 'SUPPL ', 'submission_number': 122} |
80,680 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
DEFENCATH safely and effectively. See full prescribing
information for DEFENCATH.
DEFENCATH® (taurolidine and heparin) catheter lock solution, for
central venous catheter instillation use
Initial U.S. ... | custom-source | 2025-02-12T15:48:00.318381 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214520s003lbl.pdf', 'application_number': 214520, 'submission_type': 'SUPPL ', 'submission_number': 3} |
80,678 |
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 | 2025-02-12T15:48:00.481809 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020657s043lbl.pdf', 'application_number': 20657, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,681 |
... | custom-source | 2025-02-12T15:48:00.669958 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208216s007lbl.pdf', 'application_number': 208216, 'submission_type': 'SUPPL ', 'submission_number': 7} |
80,679 |
SPORANOX®
(itraconazole)
Capsules
BOXED WARNING
Congestive Heart Failure, Cardiac Effects and Drug Interactions
Congestive Heart Failure and Cardiac Effects:
• S... | custom-source | 2025-02-12T15:48:00.782786 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020083s070lbl.pdf', 'application_number': 20083, 'submission_type': 'SUPPL ', 'submission_number': 70} |
80,682 |
... | custom-source | 2025-02-12T15:48:01.208379 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s021,214410s007lbl.pdf', 'application_number': 210854, 'submission_type': 'SUPPL ', 'submission_number': 21} |
80,683 |
... | custom-source | 2025-02-12T15:48:01.550670 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s021,214410s007lbl.pdf', 'application_number': 214410, 'submission_type': 'SUPPL ', 'submission_number': 7} |
80,684 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VEKLURY safely and effectively. See full prescribing information
for VEKLURY.
VEKLURY® (remdesivir) for injection, for intravenous use
VEKLURY® (remdesivir) injection, f... | custom-source | 2025-02-12T15:48:02.756877 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214787s029lbl.pdf', 'application_number': 214787, 'submission_type': 'SUPPL ', 'submission_number': 29} |
80,685 |
... | custom-source | 2025-02-12T15:48:03.107203 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205834s036,212477s006lbl.pdf', 'application_number': 205834, 'submission_type': 'SUPPL ', 'submission_number': 36} |
80,692 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ALYFTREK safely and effec... | custom-source | 2025-02-12T15:48:03.380575 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218730s000lbl.pdf', 'application_number': 218730, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,695 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SKYCLARYS safely and effectively. See full prescribing
information for SKYCLARYS.
SKYCLARYS® (omaveloxolone) capsules, for oral use
Initial U.S. Approval: 2023
-----------------------------RECENT MAJOR... | custom-source | 2025-02-12T15:48:03.909598 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216718s008s009lbl.pdf', 'application_number': 216718, 'submission_type': 'SUPPL ', 'submission_number': 8} |
80,696 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SKYCLARYS safely and effectively. See full prescribing
information for SKYCLARYS.
SKYCLARYS® (omaveloxolone) capsules, for oral use
Initial U.S. Approval: 2023
-----------------------------RECENT MAJOR... | custom-source | 2025-02-12T15:48:03.939112 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216718s008s009lbl.pdf', 'application_number': 216718, 'submission_type': 'SUPPL ', 'submission_number': 9} |
80,698 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SYFOVRE safely and effectively. See full prescribing information for
SYFOVRE.
SYFOVRE ® (pegcetacoplan injection), for intravitreal use
Initial U.S. Approval: 2021
------------------------... | custom-source | 2025-02-12T15:48:05.367305 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217171s002lbl.pdf', 'application_number': 217171, 'submission_type': 'SUPPL ', 'submission_number': 2} |
80,686 |
... | custom-source | 2025-02-12T15:48:05.442665 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205834s036,212477s006lbl.pdf', 'application_number': 212477, 'submission_type': 'SUPPL ', 'submission_number': 6} |
80,697 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
IMCIVREE safely and effectively. See full prescribing information for
IMCIVREE
IMCIVREE® (setmelanotide) injection, for subcutaneous use
Initial U.S. Approval: 2020
_________________ RECENT MAJOR CHANGES __... | custom-source | 2025-02-12T15:48:05.623688 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213793s007lbl.pdf', 'application_number': 213793, 'submission_type': 'SUPPL ', 'submission_number': 7} |
80,699 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
XIGDUO XR safely and effectively. See full prescribing information for
XIGDUO XR.
XIGDUO® XR (dapagliflozin and metformin hydrochloride
extended-release) tablets, for oral use
Initial U.S. Approval: 201... | custom-source | 2025-02-12T15:48:06.277228 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205649s023lbl.pdf', 'application_number': 205649, 'submission_type': 'SUPPL ', 'submission_number': 23} |
80,701 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
REVATIO safely and effectively. See full prescribing information for
REVATIO.
REVATIO (sildenafil) tablets, for oral use
REVATIO (sildenafil) for oral suspension
REVATIO (sildenafil) injection, for intravenous us... | custom-source | 2025-02-12T15:48:06.357653 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021845Orig1s028lbl.pdf', 'application_number': 21845, 'submission_type': 'SUPPL ', 'submission_number': 28} |
80,729 |
... | custom-source | 2025-02-12T15:48:07.026633 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761073s010lbl.pdf', 'application_number': 761073, 'submission_type': 'SUPPL ', 'submission_number': 10} |
80,731 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
IMBRUVICA safely and effectively. See full prescribing information for
IMBRUVICA.
IMBRUVICA® (ibrutinib) capsules, for oral use
IMBRUVICA® (ibrutinib) tablets, for oral use
IMBRUVICA® (ibrutinib) oral su... | custom-source | 2025-02-12T15:48:09.099585 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205552s043,210563s019,217003s004lbl.pdf', 'application_number': 210563, 'submission_type': 'SUPPL ', 'submission_number': 19} |
80,730 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
IMBRUVICA safely and effectively. See full prescribing information for
IMBRUVICA.
IMBRUVICA® (ibrutinib) capsules, for oral use
IMBRUVICA® (ibrutinib) tablets, for oral use
IMBRUVICA® (ibrutinib) oral su... | custom-source | 2025-02-12T15:48:09.915280 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205552s043,210563s019,217003s004lbl.pdf', 'application_number': 205552, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,732 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
IMBRUVICA safely and effectively. See full prescribing information for
IMBRUVICA.
IMBRUVICA® (ibrutinib) capsules, for oral use
IMBRUVICA® (ibrutinib) tablets, for oral use
IMBRUVICA® (ibrutinib) oral su... | custom-source | 2025-02-12T15:48:10.443311 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205552s043,210563s019,217003s004lbl.pdf', 'application_number': 217003, 'submission_type': 'SUPPL ', 'submission_number': 4} |
80,733 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not i... | custom-source | 2025-02-12T15:48:10.516894 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s002,761425s002lbl.pdf', 'application_number': 761373, 'submission_type': 'SUPPL ', 'submission_number': 2} |
80,737 |
________________________________________________________________________________________________________________________... | custom-source | 2025-02-12T15:48:10.778741 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050755s031lbl.pdf', 'application_number': 50755, 'submission_type': 'SUPPL ', 'submission_number': 31} |
80,738 | I
I
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AUGMENTIN XR safely and effectively. See full prescribing
information for AUGMENTIN XR.
AUGMENTIN XR® (amoxicillin and clavulanate potassium)
extended- release tablets, for oral use.
Initial U.S. Ap... | custom-source | 2025-02-12T15:48:11.606549 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050785s019lbl.pdf', 'application_number': 50785, 'submission_type': 'SUPPL ', 'submission_number': 19} |
80,735 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not i... | custom-source | 2025-02-12T15:48:11.807206 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s002,761425s002lbl.pdf', 'application_number': 761425, 'submission_type': 'SUPPL ', 'submission_number': 2} |
80,746 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
IBRANCE safely and effectively. See full prescribing information for
IBRANCE.
IBRANCE® (palbociclib) capsules, for oral use
Initial U.S. Approval: 2015
--------------------------- INDICATIONS AND USAGE... | custom-source | 2025-02-12T15:48:11.840679 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207103s022lbl.pdf', 'application_number': 207103, 'submission_type': 'SUPPL ', 'submission_number': 22} |
80,747 |
... | custom-source | 2025-02-12T15:48:12.361853 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212436s010lbl.pdf', 'application_number': 212436, 'submission_type': 'SUPPL ', 'submission_number': 10} |
80,748 |
... | custom-source | 2025-02-12T15:48:12.970276 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761261s004lbl.pdf', 'application_number': 761261, 'submission_type': 'SUPPL ', 'submission_number': 4} |
80,749 |
... | custom-source | 2025-02-12T15:48:13.267130 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212480s004,204671s019lbl.pdf', 'application_number': 212480, 'submission_type': 'SUPPL ', 'submission_number': 4} |
80,751 |
______________________________________________________________________________... | custom-source | 2025-02-12T15:48:13.691753 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207793s018lbl.pdf', 'application_number': 207793, 'submission_type': 'SUPPL ', 'submission_number': 18} |
80,752 |
... | custom-source | 2025-02-12T15:48:14.010808 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019414s034lbl.pdf', 'application_number': 19414, 'submission_type': 'SUPPL ', 'submission_number': 34} |
80,750 |
... | custom-source | 2025-02-12T15:48:14.108206 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212480s004,204671s019lbl.pdf', 'application_number': 204671, 'submission_type': 'SUPPL ', 'submission_number': 19} |
80,754 |
... | custom-source | 2025-02-12T15:48:14.771366 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216593Orig2s000lbl.pdf', 'application_number': 216593, 'submission_type': 'ORIG ', 'submission_number': 2} |
80,753 |
... | custom-source | 2025-02-12T15:48:14.832462 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021345s052lbl.pdf', 'application_number': 21345, 'submission_type': 'SUPPL ', 'submission_number': 52} |
80,758 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TEVIMBRA safely and effectively. See full prescribing information for
TEVIMBRA.
TEVIMBRA® (tislelizumab-jsgr) injection, for intravenous... | custom-source | 2025-02-12T15:48:15.098625 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761417s000lbl.pdf', 'application_number': 761417, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,760 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
EBANGA™ safely and effectively. See full prescribing i... | custom-source | 2025-02-12T15:48:15.922379 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761172s008lbl.pdf', 'application_number': 761172, 'submission_type': 'SUPPL ', 'submission_number': 8} |
80,756 |
... | custom-source | 2025-02-12T15:48:16.227117 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761219s013lbl.pdf', 'application_number': 761219, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,772 |
... | custom-source | 2025-02-12T15:48:18.340535 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209803s008lbledt.pdf', 'application_number': 209803, 'submission_type': 'SUPPL ', 'submission_number': 8} |
80,767 |
... | custom-source | 2025-02-12T15:48:18.433181 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761285s001,761331s001lbl.pdf', 'application_number': 761331, 'submission_type': 'SUPPL ', 'submission_number': 1} |
80,765 |
... | custom-source | 2025-02-12T15:48:18.571525 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761285s001,761331s001lbl.pdf', 'application_number': 761285, 'submission_type': 'SUPPL ', 'submission_number': 1} |
80,774 |
... | custom-source | 2025-02-12T15:48:18.777598 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209805s017lbledt.pdf', 'application_number': 209805, 'submission_type': 'SUPPL ', 'submission_number': 17} |
80,782 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
EXONDYS 51® safely and effectively. See full prescribing information
for EXONDYS 51.
EXONDYS 51 (eteplirsen) injection, for intravenous use
Initial U.S. Approval: 2016
__________________ INDICATIONS ... | custom-source | 2025-02-12T15:48:19.801657 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206488s035lbl.pdf', 'application_number': 206488, 'submission_type': 'SUPPL ', 'submission_number': 35} |
80,776 |
... | custom-source | 2025-02-12T15:48:20.348749 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209806s011lbledt.pdf', 'application_number': 209806, 'submission_type': 'SUPPL ', 'submission_number': 11} |
80,788 |
... | custom-source | 2025-02-12T15:48:21.149172 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217150s001lbl.pdf', 'application_number': 217150, 'submission_type': 'SUPPL ', 'submission_number': 1} |
80,790 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
REZUROCK safely an... | custom-source | 2025-02-12T15:48:22.395522 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214783s007lbl.pdf', 'application_number': 214783, 'submission_type': 'SUPPL ', 'submission_number': 7} |
80,791 |
... | custom-source | 2025-02-12T15:48:23.339215 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125291s161lbl.pdf', 'application_number': 125291, 'submission_type': 'SUPPL ', 'submission_number': 161} |
80,778 |
HIGHLIGHTS OF PRESC... | custom-source | 2025-02-12T15:48:23.446084 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761429s000lbl.pdf', 'application_number': 761429, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,780 |
HIGHLIGHTS OF PRESC... | custom-source | 2025-02-12T15:48:23.527979 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761381s000lbl.pdf', 'application_number': 761381, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,794 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
STIOLTO RESPIMAT safely and effectively. See full prescribing
information for STIOLTO RESPIMAT.
STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol inhalation
spray), for oral inhalation use
Init... | custom-source | 2025-02-12T15:48:23.946370 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206756Orig1s036lbl.pdf', 'application_number': 206756, 'submission_type': 'SUPPL ', 'submission_number': 36} |
80,798 |
For more information about
SPIRIVA RESPIMAT, including current
prescribing information, a video
demonstration or a Quick Start
Guide on how to use SPIRIVA RESPIMAT,
go to www.spiriva.com, scan the code, or
call 1-800-542-6257.
2.5 mcg/actuation*
2.5 mcg/actuation*
2.5 mcg/actuation*
2.5 mcg/actuation*
ABCD
4 Gra... | custom-source | 2025-02-12T15:48:24.044362 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021936Orig1s036lbl.pdf', 'application_number': 21936, 'submission_type': 'SUPPL ', 'submission_number': 36} |
80,800 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ATROVENT HFA safely and effectively. See full prescribing
information for ATROVENT HFA.
ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for
oral inhalation use
Initial U.S. Approval: 2004
... | custom-source | 2025-02-12T15:48:24.128414 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021527Orig1s042lbl.pdf', 'application_number': 21527, 'submission_type': 'SUPPL ', 'submission_number': 42} |
80,812 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Injectafer safely and effectively. See full prescribing information for
Injectafer.
INJECTAFER® (ferric carboxymaltose injection), for intravenous use
Initial U.S. Approval: 2013
-------------------... | custom-source | 2025-02-12T15:48:24.322685 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203565s027lbl.pdf', 'application_number': 203565, 'submission_type': 'SUPPL ', 'submission_number': 27} |
80,796 | custom-source | 2025-02-12T15:48:24.327525 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203108Orig1s023lbl.pdf', 'application_number': 203108, 'submission_type': 'SUPPL ', 'submission_number': 23} | |
80,801 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SPIRIVA HANDIHALER safely and effectively. See full prescribing
information for SPIRIVA HANDIHALER.
SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder),
for oral inhalation use
Initial U.S. App... | custom-source | 2025-02-12T15:48:24.507778 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf', 'application_number': 21395, 'submission_type': 'SUPPL ', 'submission_number': 78} |
80,814 |
... | custom-source | 2025-02-12T15:48:24.933783 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211810s013lbl.pdf', 'application_number': 211810, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,819 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PYRUKYND safely and effectively. See full prescribing information for
PYRUKYND.
PYRUKYND® (mitapivat) tablets, for oral use
Initial U.S. Approval: 2022
----------------------------RECENT MAJOR CHANGES----... | custom-source | 2025-02-12T15:48:25.359900 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216196s004lbl.pdf', 'application_number': 216196, 'submission_type': 'SUPPL ', 'submission_number': 4} |
80,824 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use METHYLIN® Chewable Tablets safely and effectively. See
full prescribing information for METHYLIN® Chewable Tablets.
METHYLIN® Chewable Tablets (methylphenidate hydrochloride),
for oral use, CII
Initial U.... | custom-source | 2025-02-12T15:48:25.404698 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/21475s013lbl.pdf', 'application_number': 21475, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,821 |
... | custom-source | 2025-02-12T15:48:25.449860 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021171s060lbl.pdf', 'application_number': 21171, 'submission_type': 'SUPPL ', 'submission_number': 60} |
80,837 |
--------------------------------------------------------------------------------------------
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 | 2025-02-12T15:48:25.701892 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022051Orig1s024,205434Orig1s017lbl.pdf', 'application_number': 205434, 'submission_type': 'SUPPL ', 'submission_number': 17} |
80,841 |
--------------------------------------------------------------------------------------------
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 | 2025-02-12T15:48:25.717564 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022051Orig1s024,205434Orig1s017lbl.pdf', 'application_number': 22051, 'submission_type': 'SUPPL ', 'submission_number': 24} |
80,843 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
T... | custom-source | 2025-02-12T15:48:26.040342 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211801s012lbl.pdf', 'application_number': 211801, 'submission_type': 'SUPPL ', 'submission_number': 12} |
80,842 |
... | custom-source | 2025-02-12T15:48:26.621851 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214787s030lbl.pdf', 'application_number': 214787, 'submission_type': 'SUPPL ', 'submission_number': 30} |
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