id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
11,406 | 150% FOR PROOFREADING
®
Uses I temporarily relieves minor aches and pains due to: headache,
muscular aches, menstrual cramps, the common cold, backache,
toothache, minor pain of arthritis. I temporarily reduces fever
Warnings I Ask your doctor before use if you are pregnant, under a
doctor’s care for a seri... | custom-source | 2025-02-12T13:45:11.706386 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018989s067lbl.pdf', 'application_number': 18989, 'submission_type': 'SUPPL ', 'submission_number': 67} |
11,410 | 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
| custom-source | 2025-02-12T13:45:11.791324 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19009s6lbl.pdf', 'application_number': 19009, 'submission_type': 'SUPPL ', 'submission_number': 6} |
11,409 |
VASOTEC ® TABLETS (ENALAPRIL)
NDA 018998
Proposed Labeling
Page 1 of 20
TABLETS
VASOTEC® (ENALAPRIL)
Rx Only
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
• When pregnancy is detected, discontinue Vasotec® as soon as possible.
• Drugs that ac... | custom-source | 2025-02-12T13:45:11.806549 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s077lbl.pdf', 'application_number': 18998, 'submission_type': 'SUPPL ', 'submission_number': 77} |
11,411 | Structural Formula
LUPRON® INJECTION
(leuprolide acetate)
Rx only
DESCRIPTION
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing
hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical
name is 5-oxo... | custom-source | 2025-02-12T13:45:12.040167 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf', 'application_number': 19010, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,414 | custom-source | 2025-02-12T13:45:12.043351 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016_Ibuprofen_prntlbl.pdf', 'application_number': 19012, 'submission_type': 'SUPPL ', 'submission_number': 16} | |
11,412 |
structural formula
Lupron (leuprolide acetate) Injection, Solution
[Abbott Laboratories]
Rx only
DESCRIPTION
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing
hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. Th... | custom-source | 2025-02-12T13:45:12.153186 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s035lbl.pdf', 'application_number': 19010, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,413 | structural formula
LUPRON® INJECTION
(leuprolide acetate)
Rx only
DESCRIPTION
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin
releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural
hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-... | custom-source | 2025-02-12T13:45:12.277575 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019010s037lbl.pdf', 'application_number': 19010, 'submission_type': 'SUPPL ', 'submission_number': 37} |
11,416 | 07-19-47-258
3% and 5% Sodium Chloride Injection, USP
in VIAFLEX Plastic Container
Description
3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic,
hypertonic solution for fluid and electrolyte replenishment in single dose
containers for intravenous administration. The pH may have been
adjusted with hy... | custom-source | 2025-02-12T13:45:12.371573 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019022s021lbl.pdf', 'application_number': 19022, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,415 | NDA 19-018/S-018
Page 5
Y36-002-484
PACKAGE INSERT
TrophAmine® (Amino Acid Injections)
Protect from light until use. Rx only
DESCRIPTION
TrophAmine (6% and 10% Amino Acid Injections) are sterile, nonpyrogenic, hypertonic solutions containing
crystalline amino acids.
All amino aci... | custom-source | 2025-02-12T13:45:12.578273 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19018scs018_trophamine_lbl.pdf', 'application_number': 19018, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,418 |
----------
PERIDEX - chlorhexidine gluconate mouthwash
3M
Peridex™ (CHLORHEXIDINE GLUCONATE 0.12%) ORAL RINSE
DESCRIPTION
Peridex is an oral rinse containing 0.12% chlorhexidine gluconate (1, 11-hexamethylene
bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing wate... | custom-source | 2025-02-12T13:45:12.736414 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s020lbl.pdf', 'application_number': 19028, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,419 |
----------
PERIDEX - chlorhexidine gluconate mouthwash
3M
Peridex™ (CHLORHEXIDINE GLUCONATE 0.12%) ORAL RINSE
DESCRIPTION
Peridex is an oral rinse containing 0.12% chlorhexidine gluconate (1, 11-hexamethylene
bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water,... | custom-source | 2025-02-12T13:45:12.821815 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s022lbl.pdf', 'application_number': 19028, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,420 | Rx only
DILAUDID-HP® INJECTION 10 mg/mL
(hydromorphone hydrochloride)
CII
WARNING: DILAUDID-HP® (HIGH POTENCY) IS A HIGHLY CONCENTRATED
SOLUTION OF HYDROMORPHONE, A POTENT SCHEDULE II CONTROLLED OPIOID
AGONIST, INTENDED FOR USE IN OPIOID-TOLERANT PATIENTS. DO NOT CONFUSE
DILAUDID-HP WITH STANDARD PARENT... | custom-source | 2025-02-12T13:45:12.925687 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019034s012lbl.pdf', 'application_number': 19034, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,417 | NDA 13-684/S-092, 16-677/S-139, 16-678/S-100, 16-679/S-099, 16-682/S-100,
16-683/S-096, 16-687/S-097, 16-689/S-100, 16-692/S-091, 16-693/S-091,
16-695/S-093, 16-696/S-094, 16-697/S-093, 17-378/S-063, 17-385/S-055,
17-390/S-060, 17-438/S-059, 17-451/S-058, 17-484/S-062, 17-634/S-065,
17-648/S-065, 18-008/S-065, 1... | custom-source | 2025-02-12T13:45:13.363675 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf', 'application_number': 19022, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,422 |
NDA 18925/S-007
NDA 19038/S-003
Page 4
Calan
(verapamil hydrochloride)
For Intravenous Injection
DESCRIPTION
Calan (verapamil HCl) is a calcium antagonist or slow-channel inhibitor available as a sterile solution for
intravenous injection in 5-mg (2 ml) ampule... | custom-source | 2025-02-12T13:45:13.476309 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018925s007,019038s003lbl.pdf', 'application_number': 19038, 'submission_type': 'SUPPL ', 'submission_number': 3} |
11,423 |
CALAN®
(verapamil hydrochloride)
For Intravenous Injection
DESCRIPTION
CALAN (verapamil HCl) is a calcium antagonist or slow-channel inhibitor available as a sterile
solution for intravenous injection in 5-mg (2 ml) ampules, 5-mg (2 ml) and 10-mg (4 ml)
syringes, and 5-mg (2 ml... | custom-source | 2025-02-12T13:45:13.553005 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019038s004lbl.pdf', 'application_number': 19038, 'submission_type': 'SUPPL ', 'submission_number': 4} |
11,421 | NDA 19-034/S-018-Label
Page 1
DILAUDID® and DILAUDID-HP® INJECTION
1 mg/mL, 2 mg/mL, 4mg/mL, and 10 mg/mL
(hydromorphone hydrochloride)
C-II
WARNING: DILAUDID-HP (high potency, 10 mg/mL ampules and vials) is a more
concentrated solution of hydromorphone than DILAUDID INJECTION, and is intended for
use only i... | custom-source | 2025-02-12T13:45:13.578711 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019034s018lbl.pdf', 'application_number': 19034, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,424 | 1
INDIUM In 111 OXYQUINOLINE SOLUTION
For the Radiolabeling of Autologous Leukocytes
Rx ONLY
Diagnostic—For intravenous use
For single dose, single use only
DESCRIPTION
Indium In 111 oxyquinoline (oxine) is a diagnostic radiopharmaceutical intended for
radiolabeling autologous leukocytes. It is supplied as ... | custom-source | 2025-02-12T13:45:13.662684 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/019044Orig1s000lbl.pdf', 'application_number': 19044, 'submission_type': 'ORIG ', 'submission_number': 1} |
11,426 | RETIN-A®
Cream Gel Liquid
(tretinoin)
For Topical Use Only
Prescribing Information
Description: RETIN-A Gel, Cream, and Liquid, containing tretinoin are used for the topical treatment of acne
vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two ... | custom-source | 2025-02-12T13:45:13.842431 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 19049, 'submission_type': 'SUPPL ', 'submission_number': 7} |
11,427 | RETIN-A®
Cream Gel Liquid
(tretinoin)
For Topical Use Only
Prescribing Information
Description: RETIN-A Gel, Cream, and Liquid, containing tretinoin are used for the topical treatment of acne
vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two ... | custom-source | 2025-02-12T13:45:13.850762 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf', 'application_number': 19049, 'submission_type': 'SUPPL ', 'submission_number': 8} |
11,429 |
Sufentanil Citrate Injection, USP CII
Rx only
DESCRIPTION
Sufentanil Citrate Injection, USP is a potent opioid analgesic chemically designated as N-[4-(methyoxymethyl)-1
[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamid... | custom-source | 2025-02-12T13:45:14.279562 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019050s032lbl.pdf', 'application_number': 19050, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,425 | NDA 13-684/S-092, 16-677/S-139, 16-678/S-100, 16-679/S-099, 16-682/S-100,
16-683/S-096, 16-687/S-097, 16-689/S-100, 16-692/S-091, 16-693/S-091,
16-695/S-093, 16-696/S-094, 16-697/S-093, 17-378/S-063, 17-385/S-055,
17-390/S-060, 17-438/S-059, 17-451/S-058, 17-484/S-062, 17-634/S-065,
17-648/S-065, 18-008/S-065, 1... | custom-source | 2025-02-12T13:45:14.573252 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf', 'application_number': 19047, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,428 | 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
10 Ampules (5 mL each)
LOT
EXP.
For your convenience in
... | custom-source | 2025-02-12T13:45:14.765400 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019050s031lbl.pdf', 'application_number': 19050, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,430 | DN1075V1 CR 25-003537
August 22, 2005
Page 1 of 22
(Nos. 3805, 3806, 3807, 3808)
NEW
HYTRIN®
(terazosin hydrochloride)
Capsules
DESCRIPTION
HYTRIN (terazosin hydrochloride), an alpha-1-selective adrenoceptor blocking agent, is
a quinazoline derivative represented by the following chemical name and stru... | custom-source | 2025-02-12T13:45:14.908825 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19057Orig1s021, 20347Orig1s009 lbl.pdf', 'application_number': 19057, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,431 |
----------
HYTRIN - terazosin hydrochloride tablet
Abbott Laboratories
HYTRIN®
(terazosin hydrochloride)
Description
HYTRIN (terazosin hydrochloride), an alpha-1-selective adrenoceptor blocking agent, is a quinazoline
derivative represented by the following chemical name and structural formula:
... | custom-source | 2025-02-12T13:45:14.917842 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019057s022lbl.pdf', 'application_number': 19057, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,432 |
_________________... | custom-source | 2025-02-12T13:45:15.017657 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf', 'application_number': 19071, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,433 | NDA 19-079/S-024
Page 3
Flarex
(fluorometholone acetate ophthalmic suspension)
Sterile
DESCRIPTION: FLAREX® (fluorometholone acetate ophthalmic suspension) is a corticosteroid
prepared as a sterile topical ophthalmic suspension. The active ingredient, fluorometholone acetate, is a
white to creamy white pow... | custom-source | 2025-02-12T13:45:15.304328 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019079s024lbl.pdf', 'application_number': 19079, 'submission_type': 'SUPPL ', 'submission_number': 24} |
11,434 | NDA 19-081/S-036/039
Page 4
Estraderm®
estradiol transdermal system
Continuous delivery for twice-weekly application
Rx only
Prescribing Information
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagno... | custom-source | 2025-02-12T13:45:15.377454 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf', 'application_number': 19081, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,436 | Tussionex®
Pennkinetic®
(hydrocodone polistirex and chlorpheniramine polistirex)
Extended-Release Suspension
Rx only
Rev. 01/2008 1E
DESCRIPTION
Each teaspoonful (5 mL) of TUSSIONEX Pennkinetic Extended-Release Suspension contains
hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and c... | custom-source | 2025-02-12T13:45:15.428412 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019111s015lbl.pdf', 'application_number': 19111, 'submission_type': 'SUPPL ', 'submission_number': 15} |
11,435 | NDA 19-081/S-040
Page 3
Estraderm®
estradiol transdermal system
Continuous delivery for twice-weekly application
Rx only
Prescribing Information
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measure... | custom-source | 2025-02-12T13:45:15.514513 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081s040lbl.pdf', 'application_number': 19081, 'submission_type': 'SUPPL ', 'submission_number': 40} |
11,440 |
ISOPTIN® SR
(verapamil HCl)
Sustained-Release Oral Tablets
Rx only
DESCRIPTION
ISOPTIN® SR (verapamil hydrochloride) is a calcium ion influx inhibitor (slow channel blocker
or calcium ion antagonist). ISOPTIN SR is available for oral administration as light green,
capsule shaped, scored, film-coa... | custom-source | 2025-02-12T13:45:15.776727 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019152s035lbl.pdf', 'application_number': 19152, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,437 |
Locoid®
(hydrocortisone butyrate) Solution, 0.1%
For topical use
DESCRIPTION
Locoid® (hydrocortisone butyrate) Solution, 0.1% contains the to... | custom-source | 2025-02-12T13:45:15.816258 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019116s009lbl.pdf', 'application_number': 19116, 'submission_type': 'SUPPL ', 'submission_number': 9} |
11,438 |
NDA 19-152/S-032
Page 3
ISOPTIN® SR
(verapamil HCl)
Sustained-Release Oral Tablets
Rx only
DESCRIPTION
ISOPTIN® SR (verapamil hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or
calcium ion antagonist). ISOPTIN SR is available for... | custom-source | 2025-02-12T13:45:15.931429 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019152s032lbl.pdf', 'application_number': 19152, 'submission_type': 'SUPPL ', 'submission_number': 32} |
11,439 |
NDA 19152/S-033
Page 3
Isoptin SR
(verapamil HCl)
Sustained-Release Oral Tablets
Rx only
DESCRIPTION
Isoptin SR (verapamil hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or
calcium ion antagonist). Isoptin SR is available for... | custom-source | 2025-02-12T13:45:15.934538 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019152s033lbl.pdf', 'application_number': 19152, 'submission_type': 'SUPPL ', 'submission_number': 33} |
11,444 | DESCRIPTION
CARAFATE Suspension contains sucralfate and sucralfate is an a-D-glucopyranoside, ß-D-
fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
CARAFATE Suspension for oral administration contains 1 g of sucralfate per 10 mL.
CARAFATE Suspension also contains: colloidal silicon dioxide NF, FD&C... | custom-source | 2025-02-12T13:45:16.144484 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019183s011lbl.pdf', 'application_number': 19183, 'submission_type': 'SUPPL ', 'submission_number': 11} |
11,442 | NDA 19-155/S-022
Page 3
Lac-Hydrin® (ammonium lactate) Lotion, 12%
For Dermatologic use only. Not for Ophthalmic, Oral or Intravaginal use.
DESCRIPTION
Lac-Hydrin specially formulates 12% lactic acid, neutralized with ammonium hydroxide, as
ammonium lactate to provide a lotion pH of 4.5-5.5. Lac-Hydrin (ammoniu... | custom-source | 2025-02-12T13:45:16.164485 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019155s022lbl.pdf', 'application_number': 19155, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,446 |
CARAFATE®
(sucralfate)
Suspension
DESCRIPTION
CARAFATE Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D
fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
st
ruc
tur
al
fo
rm
ula
... | custom-source | 2025-02-12T13:45:16.377877 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf', 'application_number': 19183, 'submission_type': 'SUPPL ', 'submission_number': 16} |
11,445 |
CARAFATE®
(sucralfate)
Suspension
DESCRIPTION
CARAFATE Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D
fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
st
ruc
tur
al
fo
rm
ula
... | custom-source | 2025-02-12T13:45:16.425193 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019183s014lbl.pdf', 'application_number': 19183, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,443 | NDA 19-157/S-018
Page 1
Prednisolone Sodium
Phosphate, USP, Oral Solution
6.7 mg / 5 mL
Rx Only
R539A
Rev. 5/04
DESCRIPTION: Prednisolone sodium phosphate, USP, oral solution is a dye free, colorless to
light straw colored, raspberry flavored solution. Each 5 mL (teaspoonful) contains 6.7 mg
prednisolone ... | custom-source | 2025-02-12T13:45:16.467626 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19157s018lbl.pdf', 'application_number': 19157, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,441 |
1
CALAN® SR
(verapamil hydrochloride)
Sustained-Release
Oral Caplets
DESCRIPTION
CALAN SR (verapamil hydrochloride) is a calcium ion influx inhibitor (slow-channel
blocker or calcium ion antagonist). CALAN SR is available for oral administration as
light green, capsule-shaped, scored, film-coated tablets ... | custom-source | 2025-02-12T13:45:16.596212 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019152s038lbl.pdf', 'application_number': 19152, 'submission_type': 'SUPPL ', 'submission_number': 38} |
11,449 | Voltaren®
(diclofenac sodium enteric-coated tablets)
Tablets of 25 mg, 50 mg, and 75 mg
Rx only
Prescribing Information
DESCRIPTION
Voltaren® (diclofenac sodium enteric-coated tablets) is a benzene-
acetic acid derivative. Voltaren is available as delayed-release (enteric-
coated) tablets of 25 mg (yellow), 50 mg (ligh... | custom-source | 2025-02-12T13:45:16.982072 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019201s036lbl.pdf', 'application_number': 19201, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,448 | PROVOCHOLINECI
brand of
methacholine chloride
POWDER FOR INHALATION
NOT FOR INJECTION
PROVOCHOLlNE'" (METHACHOLINE
CHLORIDE POWDER FOR INHALATION) IS
A BRONCHOCONSTRICTOR AGENT FOR
DIAGNOSTIC PURPOSES ONLY AND SHOULD
NOT BE USED AS A THERAPEUTIC AGENT.
PROVOCHOLlNE'" INHALATION CHALLENGE
SHOULD BE PERFORM... | custom-source | 2025-02-12T13:45:17.009895 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019193s013lbl.pdf', 'application_number': 19193, 'submission_type': 'SUPPL ', 'submission_number': 13} |
11,447 | 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
| custom-source | 2025-02-12T13:45:17.111852 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/019190s036lbl.pdf', 'application_number': 19190, 'submission_type': 'SUPPL ', 'submission_number': 36} |
11,450 |
company logo
Voltaren®
(diclofenac sodium enteric-coated tablets)
Tablets of 75 mg
Rx only
Prescribing Information
CARDIOVASCULAR RISK
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may increa... | custom-source | 2025-02-12T13:45:17.116394 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf', 'application_number': 19201, 'submission_type': 'SUPPL ', 'submission_number': 39} |
11,453 | NDA 19-216/SCP-021
NDA 19-216/SLR-022
Page 3
FML FORTE®
(fluorometholone ophthalmic suspension, USP) 0.25%
sterile
DESCRIPTION
FML FORTE® sterile ophthalmic suspension is a topical anti-inflammatory product for
ophthalmic use.
Chemical Name:
Fluorometholone: 9-Fluoro-11ß, 17-dihydroxy-6α-methylpregna... | custom-source | 2025-02-12T13:45:17.539214 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf', 'application_number': 19216, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,451 |
----------
... | custom-source | 2025-02-12T13:45:17.591906 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019211s040lbl.pdf', 'application_number': 19211, 'submission_type': 'SUPPL ', 'submission_number': 40} |
11,452 |
----------
... | custom-source | 2025-02-12T13:45:17.674400 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019211s042lbl.pdf', 'application_number': 19211, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,455 | custom-source | 2025-02-12T13:45:17.810426 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf', 'application_number': 19221, 'submission_type': 'SUPPL ', 'submission_number': 26} | |
11,456 |
TABLETS VASERETIC® (ENALAPRIL MALEATE-HYDROCHLOROTHIAZIDE)
NDA 19-221
Proposed Labeling
Page 1 of 27
TABLETS
VASERETIC®
(ENALAPRIL MALEATE-HYDROCHLOROTHIAZIDE)
Rx Only
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can
ca... | custom-source | 2025-02-12T13:45:18.063631 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019221s041lbl.pdf', 'application_number': 19221, 'submission_type': 'SUPPL ', 'submission_number': 41} |
11,457 | VASERETIC® TABLETS
(ENALAPRIL MALEATE-HYDROCHLOROTHIAZIDE)
Rx Only
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue VASERETIC® as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death t... | custom-source | 2025-02-12T13:45:18.307302 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019221s044lbl.pdf', 'application_number': 19221, 'submission_type': 'SUPPL ', 'submission_number': 44} |
11,458 |
structural formula
VASERETIC® TABLETS
(ENALAPRIL MALEATE-HYDROCHLOROTHIAZIDE)
Rx only
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
• When pregnancy is... | custom-source | 2025-02-12T13:45:18.388090 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019221s045lbl.pdf', 'application_number': 19221, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,454 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:45:18.526015 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19219s20lbl.pdf', 'application_number': 19219, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,459 | 1
CARNITOR® (levocarnitine) Tablets (330 mg)
CARNITOR® (levocarnitine) Oral Solution (1 g per 10 mL multidose)
CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution (1 g per 10 mL multidose)
For oral use only. Not for parenteral use.
DESCRIPTION
CARNITOR® (levocarnitine) is a carrier molecule in the transport of ... | custom-source | 2025-02-12T13:45:18.546099 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf', 'application_number': 19257, 'submission_type': 'SUPPL ', 'submission_number': 11} |
11,463 | NDA 19-261/S-008
Page 3
PAREMYD
(hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%
sterile
DESCRIPTION
PAREMYD sterile ophthalmic solution is a topical mydriatic combination product for ophthalmic
use.
STRUCTURAL FORMULAE:
[STRUCTURE]
[STRUCTURE]
hydrox... | custom-source | 2025-02-12T13:45:18.796910 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19261s8lbl.pdf', 'application_number': 19261, 'submission_type': 'SUPPL ', 'submission_number': 8} |
11,461 | PSORCON® E Emollient Cream
(diflorasone diacetate cream) 0.05%
Prescribing Information as of December 2001.
Not For Ophthalmic Use
DESCRIPTION
Each gram of Psorcon E Emollient Cream contains 0.5 mg diflorasone diacetate in a cream base.
Chemically, diflorasone diacetate is: 6α,9-difluoro - 11ß,17,21 - trihydroxy - 16ß ... | custom-source | 2025-02-12T13:45:18.807112 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19259slr009_psorcon_lbl.pdf', 'application_number': 19259, 'submission_type': 'SUPPL ', 'submission_number': 9} |
11,460 |
s
t
r
u
c
t
u
ral
f
or
m
ula
CARNITOR® (levocarnitine) Tablets (330 mg)
CARNITOR® (levocarnitine) Oral Solution (1 g per 10 mL multidose)
CARNITOR® SF (levocarnitine... | custom-source | 2025-02-12T13:45:18.923812 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf', 'application_number': 19257, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,462 | Prescribing Information as of December 2001.
psorcon® ointment
brand of diflorasone diacetate 0.05%
Not For Ophthalmic Use
DESCRIPTION
Each gram of psorcon Ointment contains 0.5 mg diflorasone diacetate in an ointment base.
Chemically, diflorasone diacetate is 6α, 9-difluoro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-
d... | custom-source | 2025-02-12T13:45:18.987635 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019260s007lbl.pdf', 'application_number': 19260, 'submission_type': 'SUPPL ', 'submission_number': 7} |
11,466 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:45:19.137605 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/019279s010lbl.pdf', 'application_number': 19279, 'submission_type': 'SUPPL ', 'submission_number': 10} |
11,465 |
Cytotec®
misoprostol tablets
WARNINGS
CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE
PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, OR PREMATURE
BIRTH. UTERINE RUPTURE HAS BEEN REPORTED... | custom-source | 2025-02-12T13:45:19.196872 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019268s047lbl.pdf', 'application_number': 19268, 'submission_type': 'SUPPL ', 'submission_number': 47} |
11,464 | Cytotec®
(misoprostol)
WARNINGS
CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE
BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN
PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (see
also PREC... | custom-source | 2025-02-12T13:45:19.275354 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19268slr037.pdf', 'application_number': 19268, 'submission_type': 'SUPPL ', 'submission_number': 37} |
11,468 |
Reference ID: 3788314
March 2015... | custom-source | 2025-02-12T13:45:19.631575 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019292s010lbl.pdf', 'application_number': 19292, 'submission_type': 'SUPPL ', 'submission_number': 10} |
11,467 |
CYKLOKAPRON®
tranexamic acid injection
Antifibrinolytic agent
DESCRIPTION
Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid
and Water for Injection to 1 mL.
FORMULATION
Chemical Name: trans-4-(aminomethyl)cyclohexanecarboxylic acid
Structu... | custom-source | 2025-02-12T13:45:19.645300 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019281s031lbl.pdf', 'application_number': 19281, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,469 | NDA 19-297/S-028
Page 3
Pl 7834-23 I
Issued 4\2005
PATIENT INFORMATION
NOVANTRONE (noe-VAN-trone)
mitoxantrone
for injection concentrate
SERONO
For Treating Multiple Sc1erosis
Read this information carefully before you start taking NOVOVANTRONE for multiple sclerosis
(MS). This informa... | custom-source | 2025-02-12T13:45:19.732940 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019297s028lbl.pdf', 'application_number': 19297, 'submission_type': 'SUPPL ', 'submission_number': 28} |
11,470 |
NOVANTRONE® ... | custom-source | 2025-02-12T13:45:19.863131 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf', 'application_number': 19297, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,474 | custom-source | 2025-02-12T13:45:20.107340 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf', 'application_number': 19309, 'submission_type': 'SUPPL ', 'submission_number': 23} | |
11,475 |
company logo
2
45766F/Revised: May 2013
3
MAGNESIUM SULFATE
4
INJECTION, USP
5
6
50%
7
DESCRIPTION:
8
Magnesium Sulfate Injection, USP 50% is a sterile, nonpyrogenic, concentrated solution of
9
magnesium sulfate heptahydrate in Water for Injection. It is administered by the intravenous
10
(... | custom-source | 2025-02-12T13:45:20.632477 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019316s018lbl.pdf', 'application_number': 19316, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,471 |
NOVANTRONE... | custom-source | 2025-02-12T13:45:20.685703 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf', 'application_number': 19297, 'submission_type': 'SUPPL ', 'submission_number': 34} |
11,472 |
NOVANTRONE
mitoXANTRONE for injection concentrate
WARNING
NOVANTRONE (mitoxantrone for injection concentrate) should be administered under
the supervision of a physician experienced... | custom-source | 2025-02-12T13:45:20.786028 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035lbl.pdf', 'application_number': 19297, 'submission_type': 'SUPPL ', 'submission_number': 35} |
11,477 | 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
| custom-source | 2025-02-12T13:45:21.094898 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019322s018lbl.pdf', 'application_number': 19323, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,476 | 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
| custom-source | 2025-02-12T13:45:21.429660 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019322s018lbl.pdf', 'application_number': 19322, 'submission_type': 'SUPPL ', 'submission_number': 18} |
11,478 |
Heparin Sodium in 5% Dextrose Injection
Rx only
12,500 USP Heparin Units/250 mL (50 USP Heparin Units/mL)
10,000 USP Heparin Units/100 mL (100 USP Heparin Units/mL)
or 25,000 USP Heparin U... | custom-source | 2025-02-12T13:45:21.481907 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019339s054lbl.pdf', 'application_number': 19339, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,479 |
Alfentanil HCl Injection, USP CII
Rx only
DESCRIPTION
Alfentanil... | custom-source | 2025-02-12T13:45:21.760973 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019353s019lbl.pdf', 'application_number': 19353, 'submission_type': 'SUPPL ', 'submission_number': 19} |
11,473 | NDA 13-684/S-092, 16-677/S-139, 16-678/S-100, 16-679/S-099, 16-682/S-100,
16-683/S-096, 16-687/S-097, 16-689/S-100, 16-692/S-091, 16-693/S-091,
16-695/S-093, 16-696/S-094, 16-697/S-093, 17-378/S-063, 17-385/S-055,
17-390/S-060, 17-438/S-059, 17-451/S-058, 17-484/S-062, 17-634/S-065,
17-648/S-065, 18-008/S-065, 1... | custom-source | 2025-02-12T13:45:21.848366 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf', 'application_number': 19308, 'submission_type': 'SUPPL ', 'submission_number': 22} |
11,481 |
07-19-63-782
Baxter
Lactated Ringer’s and 5% Dextrose Injection, USP
in VIAFLEX Plastic Container
DESCRIPTION
Lactated Ringer’s and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for
fluid and electrolyte replenishment and caloric supply in a single dose container for
intr... | custom-source | 2025-02-12T13:45:22.094917 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf', 'application_number': 19367, 'submission_type': 'SUPPL ', 'submission_number': 26} |
11,483 |
7898531XX
TABLETS
NOROXIN®
(NORFLOXACIN)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NOROXIN†
and other antibacterial drugs, NOROXIN should be used only to treat or prevent infections that are proven
or strongly suspected to be caused by bacteria.
DE... | custom-source | 2025-02-12T13:45:22.217442 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 40} |
11,484 |
7898531XX
TABLETS
NOROXIN®
(NORFLOXACIN)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NOROXIN†
and other antibacterial drugs, NOROXIN should be used only to treat or prevent infections that are proven
or strongly suspected to be caused by bacteria.
DE... | custom-source | 2025-02-12T13:45:22.255385 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 42} |
11,480 | Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP
in Plastic Container
VIAFLEX Plus Container
07-19-47-264
Description
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is a
sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric
supply in a single do... | custom-source | 2025-02-12T13:45:22.261950 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019367s021lbl.pdf', 'application_number': 19367, 'submission_type': 'SUPPL ', 'submission_number': 21} |
11,486 |
78985XX
TABLETS
NOROXIN®
(NORFLOXACIN)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NOROXIN†
and other antibacterial drugs, NOROXIN should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by bacteria.
DESCRI... | custom-source | 2025-02-12T13:45:22.500666 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s046lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 46} |
11,487 |
TABLETS
NOROXIN®
(NORFLOXACIN)
WARNING:
Fluoroquinolones, including NOROXIN®, are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of... | custom-source | 2025-02-12T13:45:22.597031 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s052lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 52} |
11,488 |
NDA 19-384/S-054
Page 5
MEDICATION GUIDE
NOROXIN® [nor-AHK-sin]
(norfloxacin)
400 ... | custom-source | 2025-02-12T13:45:22.627887 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019384s054lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 54} |
11,485 | NDA 19-384/S-045
Page 3
TABLETS
NOROXIN®
(NORFLOXACIN)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NOROXIN† and
other antibacterial drugs, NOROXIN should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by bacteria.
DES... | custom-source | 2025-02-12T13:45:22.740348 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s045lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 45} |
11,491 |
TABLETS
NOROXIN®
(NORFLOXACIN)
WARNING:
Fluoroquinolones, including NOROXIN, are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of
age, in patients taking corticosteroid drugs, a... | custom-source | 2025-02-12T13:45:23.012072 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s062lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 62} |
11,490 |
Company logo
XXXXXXX
TABLETS
NOROXIN®
(NORFLOXACIN)
WARNING:
Fluoroquinolones, including NOROXIN, are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older p... | custom-source | 2025-02-12T13:45:23.118260 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s061lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 61} |
11,492 |
TABLETS
NOROXIN®
(NORFLOXACIN)
WARNING:
Fluoroquinolones, including NOROXIN, are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of
age, in patients taking corticosteroid drugs, and i... | custom-source | 2025-02-12T13:45:23.127352 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s063lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 63} |
11,493 |
TABLETS
NOROXIN®
(NORFLOXACIN)
WARNING:
Fluoroquinolones, including NOROXIN, are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of
age, in patients taking corticosteroid drugs, and in patients with kidney... | custom-source | 2025-02-12T13:45:23.449489 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s065lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 65} |
11,489 |
company logo
XXXXXXX
TABLETS
NOROXIN®
(NORFLOXACIN)
WARNING:
Fluoroquinolones, including NOROXIN, are associated with an increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older p... | custom-source | 2025-02-12T13:45:23.694534 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s060lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 60} |
11,494 |
TABLETS
NOROXIN®
(NORFLOXACIN)
WARNING:
Fluoroquinolones, including NOROXIN, are associated with an increased risk of tendinitis and tendon rupture in all ages. This r... | custom-source | 2025-02-12T13:45:23.696019 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s066lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 66} |
11,495 |
TABLETS
NOROXIN®
(NORFLOXACIN)
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, T... | custom-source | 2025-02-12T13:45:23.745333 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019384s067lbl.pdf', 'application_number': 19384, 'submission_type': 'SUPPL ', 'submission_number': 67} |
11,496 | NDA 19-385 /S-030/ S-031/ S-035
Page 3
5.02 PV 2271-A UCP
PERMAX®
PERGOLIDE MESYLATE
DESCRIPTION
Permax (Pergolide Mesylate) is an ergot derivative dopamine receptor agonist at both D1 and
D2 receptor sites. Pergolide mesylate is chemically designated as 8β-[(Methylthio)methyl]-6-
propylergoline monomethanesu... | custom-source | 2025-02-12T13:45:23.885156 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf', 'application_number': 19385, 'submission_type': 'SUPPL ', 'submission_number': 30} |
11,497 | NDA 19-385 /S-030/ S-031/ S-035
Page 3
5.02 PV 2271-A UCP
PERMAX®
PERGOLIDE MESYLATE
DESCRIPTION
Permax (Pergolide Mesylate) is an ergot derivative dopamine receptor agonist at both D1 and
D2 receptor sites. Pergolide mesylate is chemically designated as 8β-[(Methylthio)methyl]-6-
propylergoline monomethanesu... | custom-source | 2025-02-12T13:45:23.930729 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19385slr030,031,035_permax_lbl.pdf', 'application_number': 19385, 'submission_type': 'SUPPL ', 'submission_number': 31} |
11,499 | NDA 19-404/S-020
Page 3
OCUFEN
(flurbiprofen sodium ophthalmic solution, USP) 0.03%
Sterile
DESCRIPTION
OCUFEN (flurbiprofen sodium ophthalmic solution, USP) 0.03% is a sterile topical nonsteroidal
anti-inflammatory product for ophthalmic use.
Contains: Active: flurbiprofen sodium 0.03% (0.3 mg/m... | custom-source | 2025-02-12T13:45:24.101396 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19404scp020_ocufen_lbl.pdf', 'application_number': 19404, 'submission_type': 'SUPPL ', 'submission_number': 20} |
11,501 |
CardioGen-82 PI to FDA_July-27-2010_CLEAN.doc
HIGHLIGHTS OF PRE... | custom-source | 2025-02-12T13:45:24.293065 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019414s012lbl.pdf', 'application_number': 19414, 'submission_type': 'SUPPL ', 'submission_number': 12} |
11,498 |
HIGHLIGHTS ... | custom-source | 2025-02-12T13:45:24.368889 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019386s043lbl.pdf', 'application_number': 19386, 'submission_type': 'SUPPL ', 'submission_number': 43} |
11,500 | NDA 19-414/S-011
Page 3
NDA 19-414/S-011
Page 4
NDA 19-414/S-011
Page 5
NDA 19-414/S-011
Page 6
NDA 19-414/S-011
Page 7
NDA 19-414/S-011
Page 8
NDA 19-414/S-011
Page 9
NDA 19-414/S-011
Page 10
NDA 19-414/S-011
Page 11
NDA 1... | custom-source | 2025-02-12T13:45:24.409313 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019414s011lbl.pdf', 'application_number': 19414, 'submission_type': 'SUPPL ', 'submission_number': 11} |
11,502 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all th... | custom-source | 2025-02-12T13:45:24.464676 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019414s014lbl.pdf', 'application_number': 19414, 'submission_type': 'SUPPL ', 'submission_number': 14} |
11,503 |
NDA 19-429/S-023
Page 3
Fiorinal with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate) capsule
[Watson Pharmaceuticals, Inc.]
Rx only
DESCR... | custom-source | 2025-02-12T13:45:24.636357 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019429s023lbl.pdf', 'application_number': 19429, 'submission_type': 'SUPPL ', 'submission_number': 23} |
11,505 | ----------
EPIPEN®- epinephrine injection
EPIPEN Jr®- epinephrine injection
Mylan Specialty L.P.
EpiPen®
(epinephrine) Auto-Injector 0.3 mg
EpiPen® = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3
mL)
EpiPen Jr®
(epinephrine) Auto-Injector 0.15 mg
EpiPenJr® = one dose of 0.15 mg epinephrine... | custom-source | 2025-02-12T13:45:24.729931 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019430s053lbl.pdf', 'application_number': 19430, 'submission_type': 'SUPPL ', 'submission_number': 53} |
11,504 |
PRESCRIBING INFORMATION
logo fo ep
ipen and epipen jr, respectively
DESCRIPTION
Each EpiPen® Auto-Injector delivers a single dose of 0.3 mg epinephrine injection, USP, 1:1000
(0.3 mL) in a sterile solution.
Each EpiPen® Jr Auto-Injector delivers a single dos... | custom-source | 2025-02-12T13:45:24.822552 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019430s044lbl.pdf', 'application_number': 19430, 'submission_type': 'SUPPL ', 'submission_number': 44} |
11,506 | NDA 19-452/S-016/S-019 & S-020
Page 4
Derma-Smoothe/FS®
fluocinolone acetonide
Topical Oil, 0.01%
(Body Oil)
For Topical Use Only- NDC 28105-... | custom-source | 2025-02-12T13:45:24.956530 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf', 'application_number': 19452, 'submission_type': 'SUPPL ', 'submission_number': 16} |
11,507 | NDA 19452/S-017
Page 4
Derma-Smoothe/FS
(fluocinolone acetonide topical oil)
Topical Oil, 0.01%
For Dermatologic Use Only- NDC 28105-149-04
Not for Ophthalmic Use-
DESCRIPTION
Derma-Smoothe/FS contains fluocinolone acetoni... | custom-source | 2025-02-12T13:45:24.981637 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19452s17lbl.pdf', 'application_number': 19452, 'submission_type': 'SUPPL ', 'submission_number': 17} |
11,508 | NDAs 19-462, 19-527, 20-752
Page 3
PEPCID®
(FAMOTIDINE) TABLETS
PEPCID®
(FAMOTIDINE) FOR ORAL SUSPENSION
PEPCID RPD®
(FAMOTIDINE) ORALLY DISINTEGRATING TABLETS
DESCRIPTION
The active ingredient in PEPCID* (famotidine) is a histamine H2-receptor antagonist. Famotidine is N′-
(aminosulfonyl)-3-[[[2-[(diaminomethylene)ami... | custom-source | 2025-02-12T13:45:25.044369 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462lbl.pdf', 'application_number': 19462, 'submission_type': 'ORIG ', 'submission_number': 1} |
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