id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
80,406 |
... | custom-source | 2025-02-12T15:47:14.730912 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021926s019lbl.pdf', 'application_number': 21926, 'submission_type': 'SUPPL ', 'submission_number': 19} |
80,408 |
... | custom-source | 2025-02-12T15:47:15.022360 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217630s000lbl.pdf', 'application_number': 217630, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,409 |
... | custom-source | 2025-02-12T15:47:15.742906 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020607s043lbl.pdf', 'application_number': 20607, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,411 |
... | custom-source | 2025-02-12T15:47:16.095619 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022511s030lbl.pdf', 'application_number': 22511, 'submission_type': 'SUPPL ', 'submission_number': 30} |
80,413 |
... | custom-source | 2025-02-12T15:47:16.645187 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022519s014lbl.pdf', 'application_number': 22519, 'submission_type': 'SUPPL ', 'submission_number': 14} |
80,415 |
... | custom-source | 2025-02-12T15:47:16.798537 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205103s010lbl.pdf', 'application_number': 205103, 'submission_type': 'SUPPL ', 'submission_number': 10} |
80,436 |
... | custom-source | 2025-02-12T15:47:17.419360 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021539s019lbl.pdf', 'application_number': 21539, 'submission_type': 'SUPPL ', 'submission_number': 19} |
80,420 |
... | custom-source | 2025-02-12T15:47:17.576320 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215973s006,215974s008lbl.pdf', 'application_number': 215973, 'submission_type': 'SUPPL ', 'submission_number': 6} |
80,421 |
... | custom-source | 2025-02-12T15:47:17.952927 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215973s006,215974s008lbl.pdf', 'application_number': 215974, 'submission_type': 'SUPPL ', 'submission_number': 8} |
80,419 |
HIGHLIGHTS OF PRESCRIBING... | custom-source | 2025-02-12T15:47:18.830126 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761201s010lbl.pdf', 'application_number': 761201, 'submission_type': 'SUPPL ', 'submission_number': 10} |
80,447 |
Diastat® C-IV
(diazepam rectal gel)
Rectal Delivery System
Diastat® AcuDial™ Rectal Delivery System
(diazepam rectal gel)
DESCRIPTION
Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose,
rectal delivery system. Diazepam... | custom-source | 2025-02-12T15:47:18.950090 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020648s024lbl.pdf', 'application_number': 20648, 'submission_type': 'SUPPL ', 'submission_number': 24} |
80,450 |
... | custom-source | 2025-02-12T15:47:19.536064 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216017s000,216017s000lbl.pdf', 'application_number': 216017, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,449 |
... | custom-source | 2025-02-12T15:47:19.675046 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216017s000,216017s000lbl.pdf', 'application_number': 216016, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,445 | 10 mg each
30
Tab e s
30 TABLETS
HIVES
RELIEF
Actual Size
®
HIVES
Cetirizine HCl tablets
10mg/antihistamine
NDC 50580-116-04
Cetirizine HCl tablets
10 mg/antihistamine
The trade dress of this ZYRTEC® package is subject to trademark protection.
Active ingredient made in Switzerland
HIVES RELIEF
30
Tablets
10 mg each... | custom-source | 2025-02-12T15:47:20.127646 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s050;22155Orig1s027lbl.pdf', 'application_number': 22155, 'submission_type': 'SUPPL ', 'submission_number': 27} |
80,454 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
YESINTEK safely and effectively. See full prescribing information for
YESINTEK.
YESINTEKTM (ustekinumab-kfce) injection, for subcutaneous or
intravenous use
Initial U.S. Approval: 2024
YESINTEKTM (uste... | custom-source | 2025-02-12T15:47:20.879599 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761406s000lbl.pdf', 'application_number': 761406, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,444 | 10 mg each
30
Tab e s
30 TABLETS
HIVES
RELIEF
Actual Size
®
HIVES
Cetirizine HCl tablets
10mg/antihistamine
NDC 50580-116-04
Cetirizine HCl tablets
10 mg/antihistamine
The trade dress of this ZYRTEC® package is subject to trademark protection.
Active ingredient made in Switzerland
HIVES RELIEF
30
Tablets
10 mg each... | custom-source | 2025-02-12T15:47:21.176486 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s050;22155Orig1s027lbl.pdf', 'application_number': 19835, 'submission_type': 'SUPPL ', 'submission_number': 50} |
80,460 |
... | custom-source | 2025-02-12T15:47:22.598576 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215500s001lbl.pdf', 'application_number': 215500, 'submission_type': 'SUPPL ', 'submission_number': 1} |
80,458 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PAXIL
safely and effectively. See full prescribing information for PAXIL.
PAXIL (paroxetine) tablets, for oral use
PAXIL (paroxetine) oral suspension
Initial U.S. Approval: 1992
WARNING: SUICIDAL THOUGHTS... | custom-source | 2025-02-12T15:47:22.652620 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083,020710s051lbl.pdf', 'application_number': 20710, 'submission_type': 'SUPPL ', 'submission_number': 51} |
80,456 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PAXIL
safely and effectively. See full prescribing information for PAXIL.
PAXIL (paroxetine) tablets, for oral use
PAXIL (paroxetine) oral suspension
Initial U.S. Approval: 1992
WARNING: SUICIDAL THOUGHTS... | custom-source | 2025-02-12T15:47:22.858309 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083,020710s051lbl.pdf', 'application_number': 20031, 'submission_type': 'SUPPL ', 'submission_number': 83} |
80,465 |
--------------------------------------------------------------------------------------------
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 | 2025-02-12T15:47:23.562100 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215401Orig1s011lbl.pdf', 'application_number': 215401, 'submission_type': 'SUPPL ', 'submission_number': 11} |
80,463 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use RALDESYTM safely and effectively. See full prescribing
information for RALDESYTM.
RALDESYTM (trazodone hydrochloride) oral solution
Initial U.S. Approval: 1981
• Orthostatic Hypotension and Syncope: Wa... | custom-source | 2025-02-12T15:47:23.794403 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218637s000lbl.pdf', 'application_number': 218637, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,461 |
... | custom-source | 2025-02-12T15:47:23.827847 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s020lbl.pdf', 'application_number': 761049, 'submission_type': 'SUPPL ', 'submission_number': 20} |
80,469 |
... | custom-source | 2025-02-12T15:47:24.509458 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208082s016s017lbl.pdf', 'application_number': 208082, 'submission_type': 'SUPPL ', 'submission_number': 16} |
80,470 |
... | custom-source | 2025-02-12T15:47:25.099471 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208082s016s017lbl.pdf', 'application_number': 208082, 'submission_type': 'SUPPL ', 'submission_number': 17} |
80,474 |
... | custom-source | 2025-02-12T15:47:25.486659 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021514s039lbl.pdf', 'application_number': 21514, 'submission_type': 'SUPPL ', 'submission_number': 39} |
80,472 |
... | custom-source | 2025-02-12T15:47:25.555246 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s015lbl.pdf', 'application_number': 215256, 'submission_type': 'SUPPL ', 'submission_number': 15} |
80,476 |
... | custom-source | 2025-02-12T15:47:25.792904 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019763s021lbl.pdf', 'application_number': 19763, 'submission_type': 'SUPPL ', 'submission_number': 21} |
80,487 | NDA 020648/S-009
Page 4 of 8
Revised 10 mg Pharmacist Card
Reference ID: 3364931
NDA 020648/S-009
Page 5 of 8
Revised 20 mg Pharmacist Card
Reference ID: 3364931
NDA 020648/S-009
Page 6 of 8
Sidesert for Diastat AcuDial 10 mg and 20 mg
Reference ID: 3364931
... | custom-source | 2025-02-12T15:47:25.944571 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020648Orig1s009lbl.pdf', 'application_number': 20648, 'submission_type': 'SUPPL ', 'submission_number': 9} |
80,477 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AXTLE safely and effectively. See full prescribing information for
AXTLE.
AXTLETM (pemetrexed) for Injection, for int... | custom-source | 2025-02-12T15:47:26.535434 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210661s001lbl.pdf', 'application_number': 210661, 'submission_type': 'SUPPL ', 'submission_number': 1} |
80,506 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AXTLE safely and effectively. See full prescribing information for
AXTLE.
AXTLETM (pemetrexed) for Injection, for int... | custom-source | 2025-02-12T15:47:26.818617 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210661s001lbl.pdf', 'application_number': 210661, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,507 |
... | custom-source | 2025-02-12T15:47:27.145916 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761352s001lbl.pdf', 'application_number': 761352, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,509 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LUTATHERA safely and effectively. See full prescribing information for
LUTATHERA.
LUTATHERA® (lutetium Lu 177 dotatate) injection, for intravenous use
Initial U.S. Approval: 2018
---------------------------RECE... | custom-source | 2025-02-12T15:47:27.359498 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208700Orig1s032lbl.pdf', 'application_number': 208700, 'submission_type': 'SUPPL ', 'submission_number': 32} |
80,510 | NDA 212909/S-002
Page 4
U.S. Food & Drug Administration
Silver Spring, MD 20993
www.fda.gov
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
BIORPHEN® safely and effectively. See full prescribing information for
BIORPHEN.
BIORPHEN (phenylephrin... | custom-source | 2025-02-12T15:47:27.730215 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212909Orig1s002lbl.pdf', 'application_number': 212909, 'submission_type': 'SUPPL ', 'submission_number': 2} |
80,511 | NDA 208845/S-021
Page 4
U.S. Food & Drug Administration
Silver Spring, MD 20993
www.fda.gov
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZILRETTA safely and effectively. See full prescribing information for
... | custom-source | 2025-02-12T15:47:27.999558 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208845Orig1s021lbl.pdf', 'application_number': 208845, 'submission_type': 'SUPPL ', 'submission_number': 21} |
80,508 |
... | custom-source | 2025-02-12T15:47:28.412583 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s049lbl.pdf', 'application_number': 761069, 'submission_type': 'SUPPL ', 'submission_number': 49} |
80,515 |
... | custom-source | 2025-02-12T15:47:28.624619 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050684s105lbl.pdf', 'application_number': 50684, 'submission_type': 'SUPPL ', 'submission_number': 105} |
80,516 |
... | custom-source | 2025-02-12T15:47:28.928048 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050706s044lbl.pdf', 'application_number': 50706, 'submission_type': 'SUPPL ', 'submission_number': 44} |
80,518 |
... | custom-source | 2025-02-12T15:47:29.459920 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202106s009lbl.pdf', 'application_number': 202106, 'submission_type': 'SUPPL ', 'submission_number': 9} |
80,517 |
... | custom-source | 2025-02-12T15:47:29.480396 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050750s053lbl.pdf', 'application_number': 50750, 'submission_type': 'SUPPL ', 'submission_number': 53} |
80,520 |
... | custom-source | 2025-02-12T15:47:29.779285 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215212s002lbl.pdf', 'application_number': 215212, 'submission_type': 'SUPPL ', 'submission_number': 2} |
80,519 |
... | custom-source | 2025-02-12T15:47:29.972900 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209776s009lbl.pdf', 'application_number': 209776, 'submission_type': 'SUPPL ', 'submission_number': 9} |
80,521 |
H 0
I II
H-C-C-OH
I
0
H
Acetic Acid
Chemically, hydrocortisone is:
Pregn-4-ene-3, 20-dione,
11, 17, 21-trihydroxy-, (11~)- .
Hydrocortisone and Acetic Acid Otic Solution, USP
Rx only
DESCRIPTION: Hydrocortisone and Acetic Acid Otic Solution,... | custom-source | 2025-02-12T15:47:30.256803 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012770s033lbl.pdf', 'application_number': 12770, 'submission_type': 'SUPPL ', 'submission_number': 33} |
80,522 |
... | custom-source | 2025-02-12T15:47:30.572704 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203341s026lbl.pdf', 'application_number': 203341, 'submission_type': 'SUPPL ', 'submission_number': 26} |
80,523 |
... | custom-source | 2025-02-12T15:47:31.269280 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217729s001lbl.pdf', 'application_number': 217729, 'submission_type': 'SUPPL ', 'submission_number': 1} |
80,524 |
... | custom-source | 2025-02-12T15:47:31.352664 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216099s003lbl.pdf', 'application_number': 216099, 'submission_type': 'SUPPL ', 'submission_number': 3} |
80,525 |
... | custom-source | 2025-02-12T15:47:32.392323 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s011lbl.pdf', 'application_number': 761275, 'submission_type': 'SUPPL ', 'submission_number': 11} |
80,532 | NDA 209241/S-028
Page 3
U.S. Food & Drug Administration
Silver Spring, MD 20993
www.fda.gov
CARTON LABELS
NDA 209241/S-028
Page 4
U.S. Food & Drug Administration
Silver Spring, MD 20993
www.fda.gov
NDA 209241/S-028
Page 5
U.S. Food & Drug Administration
Silver Spring, MD 20993
www.fda.gov
NDA 2... | custom-source | 2025-02-12T15:47:32.458674 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209241orig1s028lbl.pdf', 'application_number': 209241, 'submission_type': 'SUPPL ', 'submission_number': 28} |
80,533 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION safely and
effectively. See full prescribing information for NOREPINEPHRINE IN
SODIUM CHLORIDE INJECTION.
NOREPINEPHRINE IN SODIUM CHLORIDE INJECTION, for
intraven... | custom-source | 2025-02-12T15:47:32.624202 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214628Orig1s004Correctedlbl.pdf', 'application_number': 214628, 'submission_type': 'SUPPL ', 'submission_number': 4} |
80,527 |
... | custom-source | 2025-02-12T15:47:32.735417 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761354s004lbl.pdf', 'application_number': 761354, 'submission_type': 'SUPPL ', 'submission_number': 4} |
80,539 |
... | custom-source | 2025-02-12T15:47:32.876375 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011525s039lbl.pdf', 'application_number': 11525, 'submission_type': 'SUPPL ', 'submission_number': 39} |
80,542 |
... | custom-source | 2025-02-12T15:47:33.839157 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018735s073lbl.pdf', 'application_number': 18735, 'submission_type': 'SUPPL ', 'submission_number': 73} |
80,540 |
... | custom-source | 2025-02-12T15:47:34.136951 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021567s049,206352s011lbl.pdf', 'application_number': 21567, 'submission_type': 'SUPPL ', 'submission_number': 49} |
80,543 |
... | custom-source | 2025-02-12T15:47:34.663557 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217645s001lbl.pdf', 'application_number': 217645, 'submission_type': 'SUPPL ', 'submission_number': 1} |
80,544 |
... | custom-source | 2025-02-12T15:47:35.904614 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017624s043lbl.pdf', 'application_number': 17624, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,545 |
... | custom-source | 2025-02-12T15:47:36.552083 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s020s021lbl.pdf', 'application_number': 213051, 'submission_type': 'SUPPL ', 'submission_number': 21} |
80,546 |
... | custom-source | 2025-02-12T15:47:36.740531 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s020s021lbl.pdf', 'application_number': 213051, 'submission_type': 'SUPPL ', 'submission_number': 20} |
80,541 |
... | custom-source | 2025-02-12T15:47:37.524439 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021567s049,206352s011lbl.pdf', 'application_number': 206352, 'submission_type': 'SUPPL ', 'submission_number': 11} |
80,563 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION safely and
effectively. See full prescribing information for HEPARIN SODIUM IN
SODIUM CHLORIDE INJECTION.
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION, for
intravenous... | custom-source | 2025-02-12T15:47:37.770104 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018916s080lbl.pdf', 'application_number': 18916, 'submission_type': 'SUPPL ', 'submission_number': 80} |
80,568 | Recommended Dosage:
see Prescribing Information.
Each tablet contains 0.25 mg
of brexpiprazole.
Store REXULTI® tablets at
20°C to 25°C (68°F to 77°F);
excursions permitted to
15°C to 30°C (59°F to 86°F)
[see USP Controlled Room
Temperature].
Manufactured by Otsuka
Pharmaceutical Co., Ltd., Tokyo,
101-8535... | custom-source | 2025-02-12T15:47:38.863706 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205422Orig1s013lbl.pdf', 'application_number': 205422, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,569 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NURTEC ODT safely and effectively. See full prescribing information for
NURTEC ODT.
NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or
oral use
Initial U.S. Approval: 2020
--------... | custom-source | 2025-02-12T15:47:39.149267 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212728Orig1s025Correctedlbl.pdf', 'application_number': 212728, 'submission_type': 'SUPPL ', 'submission_number': 25} |
80,561 |
... | custom-source | 2025-02-12T15:47:39.771590 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125472s058,125276s146lbl.pdf', 'application_number': 125472, 'submission_type': 'SUPPL ', 'submission_number': 58} |
80,574 |
... | custom-source | 2025-02-12T15:47:40.695788 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218808s000,218820s000lbl.pdf', 'application_number': 218808, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,575 |
... | custom-source | 2025-02-12T15:47:41.686545 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218808s000,218820s000lbl.pdf', 'application_number': 218820, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,573 |
... | custom-source | 2025-02-12T15:47:41.758349 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761391s000lbl.pdf', 'application_number': 761391, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,564 |
... | custom-source | 2025-02-12T15:47:42.219637 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125514s162lbl.pdf', 'application_number': 125514, 'submission_type': 'SUPPL ', 'submission_number': 162} |
80,576 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
UNLOXCYT safely and effectively. See full prescribing information for
UNLOXCYT.
UNLOXCYT (cosibelimab-ipdl) injection, for intravenous use
Initial U.S. Approval: 2024
---------------------------... | custom-source | 2025-02-12T15:47:42.503696 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761297s000lbl.pdf', 'application_number': 761297, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,578 |
PURIFIED CORTROPHIN® GEL
(Repos... | custom-source | 2025-02-12T15:47:42.509871 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008975s015lbl.pdf', 'application_number': 8975, 'submission_type': 'SUPPL ', 'submission_number': 15} |
80,577 |
... | custom-source | 2025-02-12T15:47:42.730662 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211109s009lbl.pdf', 'application_number': 211109, 'submission_type': 'SUPPL ', 'submission_number': 9} |
80,581 |
... | custom-source | 2025-02-12T15:47:43.549399 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206038s018,211358s006lbl.pdf', 'application_number': 211358, 'submission_type': 'SUPPL ', 'submission_number': 6} |
80,579 |
... | custom-source | 2025-02-12T15:47:43.738461 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020497s018lbl.pdf', 'application_number': 20497, 'submission_type': 'SUPPL ', 'submission_number': 18} |
80,580 |
... | custom-source | 2025-02-12T15:47:44.814310 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206038s018,211358s006lbl.pdf', 'application_number': 206038, 'submission_type': 'SUPPL ', 'submission_number': 18} |
80,583 |
... | custom-source | 2025-02-12T15:47:45.056393 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216190s000lbl.pdf', 'application_number': 216190, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,582 |
... | custom-source | 2025-02-12T15:47:45.459127 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s013lbl.pdf', 'application_number': 761275, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,584 |
... | custom-source | 2025-02-12T15:47:45.554498 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022225s014lbl.pdf', 'application_number': 22225, 'submission_type': 'SUPPL ', 'submission_number': 14} |
80,587 |
... | custom-source | 2025-02-12T15:47:45.844783 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215272s002lbl.pdf', 'application_number': 215272, 'submission_type': 'SUPPL ', 'submission_number': 2} |
80,585 | Bayer, the Bayer Cross, Claritin
and the Claritin Vista are
registered trademarks of Bayer.
© 2023 Bayer.
Dist by: Bayer HealthCare LLC
Whippany, NJ 07981
Made in India.
Pat.: patents.livewell.bayer.com
Bayer, the Bayer Cross, Claritin
and the Claritin Vista are
registered trademarks of Bayer.
© 2023 Bayer... | custom-source | 2025-02-12T15:47:46.387729 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020641Orig1s048lbl.pdf', 'application_number': 20641, 'submission_type': 'SUPPL ', 'submission_number': 48} |
80,599 |
... | custom-source | 2025-02-12T15:47:46.683854 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216578s004lbl.pdf', 'application_number': 216578, 'submission_type': 'SUPPL ', 'submission_number': 4} |
80,600 |
... | custom-source | 2025-02-12T15:47:46.950243 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021583s043lbl.pdf', 'application_number': 21583, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,601 |
... | custom-source | 2025-02-12T15:47:47.491229 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020753s025lbl.pdf', 'application_number': 20753, 'submission_type': 'SUPPL ', 'submission_number': 25} |
80,602 |
... | custom-source | 2025-02-12T15:47:47.692397 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020726s043lbl.pdf', 'application_number': 20726, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,603 |
... | custom-source | 2025-02-12T15:47:48.200690 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020541s036lbl.pdf', 'application_number': 20541, 'submission_type': 'SUPPL ', 'submission_number': 36} |
80,609 | CEFOBID®
(sterile cefoperazone)
For Intravenous or Intramuscular Use
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
CEFOBID and other antibacterial drugs, CEFOBID should be used only to treat infections that
are proven or strongly suspected to be caused by bacteria.
DESCRIP... | custom-source | 2025-02-12T15:47:48.603713 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050551s047lbl.pdf', 'application_number': 50551, 'submission_type': 'SUPPL ', 'submission_number': 47} |
80,608 |
... | custom-source | 2025-02-12T15:47:48.916833 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202236s021lbl.pdf', 'application_number': 202236, 'submission_type': 'SUPPL ', 'submission_number': 21} |
80,625 | custom-source | 2025-02-12T15:47:49.020765 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021790Orig1s023lbl.pdf', 'application_number': 21790, 'submission_type': 'SUPPL ', 'submission_number': 23} | |
80,612 |
... | custom-source | 2025-02-12T15:47:51.034266 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761338s000lbl.pdf', 'application_number': 761338, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,629 |
... | custom-source | 2025-02-12T15:47:51.198905 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf', 'application_number': 218171, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,610 |
... | custom-source | 2025-02-12T15:47:51.552287 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557s030lbl.pdf', 'application_number': 125557, 'submission_type': 'SUPPL ', 'submission_number': 30} |
80,627 |
... | custom-source | 2025-02-12T15:47:53.362058 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761255s008lbl.pdf', 'application_number': 761255, 'submission_type': 'SUPPL ', 'submission_number': 8} |
80,630 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INVOKANA safely and effectively. See full prescribing information for
INVOKANA.
INVOKANA® (canagliflozin) tablets, for oral use
Initial U.S. Approval: 2013
-------------------------RECENT MAJOR CHANGES---------... | custom-source | 2025-02-12T15:47:54.146661 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204042s043lbl.pdf', 'application_number': 204042, 'submission_type': 'SUPPL ', 'submission_number': 43} |
80,632 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INVOKAMET or INVOKAMET XR safely and effectively. See full
prescribing information for INVOKAMET or INVOKAMET XR.
INVOKAMET® (canagliflozin and metformin hydrochloride) tablets, for
oral use
INVOKAMET® XR (cana... | custom-source | 2025-02-12T15:47:54.706256 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204353s046,205879s023lbl.pdf', 'application_number': 204353, 'submission_type': 'SUPPL ', 'submission_number': 46} |
80,635 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INVOKAMET or INVOKAMET XR safely and effectively. See full
prescribing information for INVOKAMET or INVOKAMET XR.
INVOKAMET® (canagliflozin and metformin hydrochloride) tablets, for
oral use
INVOKAMET® XR (cana... | custom-source | 2025-02-12T15:47:54.718216 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204353s046,205879s023lbl.pdf', 'application_number': 205879, 'submission_type': 'SUPPL ', 'submission_number': 23} |
80,637 |
0
II
HC-
D -
C: -
CH
I
I
C: -= O
OMNIPRED® (prednisolone acetate ophthalmic suspension) 1%
DESCRIPTION: OMNIPRED® (prednisolone acetate ophthalmic suspension) is an
adrenocortical steroid product prepared as sterile ophthalmic suspension for topical ophthalmic
use. The active ingredient is represente... | custom-source | 2025-02-12T15:47:54.859439 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017469s054lbl.pdf', 'application_number': 17469, 'submission_type': 'SUPPL ', 'submission_number': 54} |
80,636 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
... | custom-source | 2025-02-12T15:47:54.901665 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213006s011lbl.pdf', 'application_number': 213006, 'submission_type': 'SUPPL ', 'submission_number': 11} |
80,639 |
... | custom-source | 2025-02-12T15:47:56.225787 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218160s004lbl.pdf', 'application_number': 218160, 'submission_type': 'SUPPL ', 'submission_number': 4} |
80,640 |
... | custom-source | 2025-02-12T15:47:56.261613 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s014lbl.pdf', 'application_number': 213246, 'submission_type': 'SUPPL ', 'submission_number': 14} |
80,638 |
... | custom-source | 2025-02-12T15:47:56.501901 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216109s003lbl.pdf', 'application_number': 216109, 'submission_type': 'SUPPL ', 'submission_number': 3} |
80,643 |
... | custom-source | 2025-02-12T15:47:56.530650 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209606s008lbl.pdf', 'application_number': 209606, 'submission_type': 'SUPPL ', 'submission_number': 8} |
80,655 |
... | custom-source | 2025-02-12T15:47:57.557921 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218614s000lbl.pdf', 'application_number': 218614, 'submission_type': 'ORIG ', 'submission_number': 1} |
80,674 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZEPBOUND safely and effectively. See full prescribing
information for ZEPBOUND.
ZEPBOUND® (tirzepatide) Injection, for subcutaneous use
Initial U.S. Approval: 2022
WARNING: RISK OF THYROID C-CELL TUMORS
See... | custom-source | 2025-02-12T15:47:58.820097 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217806s013lbl.pdf', 'application_number': 217806, 'submission_type': 'SUPPL ', 'submission_number': 13} |
80,676 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Alhemo
safely and effectively. See full prescribing information for Alhemo.
Alhemo® (concizumab-mtci) injection, for subcutaneous use
Initial U.S. Approval: 2024
--------------------------INDICATIONS AND U... | custom-source | 2025-02-12T15:47:58.828398 | {'url': 'https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761315s000lbl.pdf', 'application_number': 761315, 'submission_type': 'ORIG ', 'submission_number': 1} |
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