id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
12,682 | NDA 20-527/S-034, S-035
PREMPRO™
(conjugated estrogens/medroxyprogesterone acetate tablets)
PREMPHASE
(conjugated estrogens/medroxyprogesterone acetate tablets)
RX] only
WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease.
The Women’s Health Initiative (WHI) s... | custom-source | 2025-02-12T13:48:12.935782 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020527S034035lbl.pdf', 'application_number': 20527, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,686 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to... | custom-source | 2025-02-12T13:48:13.098741 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020527s051s052s054s056lbl.pdf', 'application_number': 20527, 'submission_type': 'SUPPL ', 'submission_number': 52} |
12,685 |
PREMPRO®
(conjugated estrogens/medroxyprogesterone acetate tablets)
PREMPHASE®
(conjugated estrogens/medroxyprogesterone acetate tablets)
Rx only
WARNINGS
CARDIOVASCULAR AND OTHER RISKS
Estrogens plus progestins should not be used for the prevention of cardiovascular disease or
dementi... | custom-source | 2025-02-12T13:48:13.240508 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020527s046lbl.pdf', 'application_number': 20527, 'submission_type': 'SUPPL ', 'submission_number': 46} |
12,688 |
MAVIK®
(trandolapril tablets)
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue MAVIK as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing
fetus (See WARNINGS: Fetal Toxicity).
DESCRIPTION
Trandolapril is the ethy... | custom-source | 2025-02-12T13:48:13.536401 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf', 'application_number': 20528, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,687 |
MAVIK®
(trandolapril tablets)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and
even death to the developing fetus. When pregnancy is detected, MAVIK should be discontinued as soon
as possible. See WARNINGS - Fetal/Neonatal Morbidity and M... | custom-source | 2025-02-12T13:48:13.596243 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s018lbl.pdf', 'application_number': 20528, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,689 |
MAVIK®
(trandolapril tablets)
WARNING: FETAL TOXICITY
• When pregnancy is detected, discontinue MAVIK as soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury and death
to the developing fetus (See WARNINGS: ... | custom-source | 2025-02-12T13:48:13.706162 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020528s024lbl.pdf', 'application_number': 20528, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,690 | NDA 20-533/S-012
Page 3
721683-05
NAROPIN
(ropivacaine HCl) Injection
Rx only
DESCRIPTION
Naropin Injection contains ropivacaine HCl which is a member of the amino amide class of local
anesthetics. Naropin Injection is a sterile, isotonic solution that contains the enantiomerically pure drug
substanc... | custom-source | 2025-02-12T13:48:13.774232 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20533s012lbl.pdf', 'application_number': 20533, 'submission_type': 'SUPPL ', 'submission_number': 12} |
12,691 |
1
451112A/Issued: February 2010
2
NAROPIN®
3
(ropivacaine HCl) Injection
4
Rx only
5
DESCRIPTION:
6
Naropin® Injection contains ropivacaine HCl, which is a member of the amino amide class of
7
local anesthetics. Naropin Injection is a sterile, isotonic solution that contains the
8
enantiomerically p... | custom-source | 2025-02-12T13:48:14.068244 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf', 'application_number': 20533, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,693 | NDA 20-538/S-019
Page 3
Vivelle-Dot®
(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 measures... | custom-source | 2025-02-12T13:48:14.239918 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538slr019_vivelle_lbl.pdf', 'application_number': 20538, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,694 |
3
Vivelle-Dot®
(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
measures, including endometrial sampli... | custom-source | 2025-02-12T13:48:14.240240 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538s024lbl.pdf', 'application_number': 20538, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,695 |
•
company logo
Vivelle-Dot®
(estradiol transdermal system)
Continuous delivery for twice-weekly application
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST
CANCER and PROBABLE DEMENTIA
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of end... | custom-source | 2025-02-12T13:48:14.485870 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf', 'application_number': 20538, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,692 | custom-source | 2025-02-12T13:48:14.504828 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_prntlbl.pdf', 'application_number': 20538, 'submission_type': 'SUPPL ', 'submission_number': 6} | |
12,697 |
... | custom-source | 2025-02-12T13:48:14.611359 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s024lbl.pdf', 'application_number': 20539, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,696 |
... | custom-source | 2025-02-12T13:48:14.949883 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020538s032lbl.pdf', 'application_number': 20538, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,698 | custom-source | 2025-02-12T13:48:15.011628 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex_prntlbl.pdf', 'application_number': 20541, 'submission_type': 'SUPPL ', 'submission_number': 6} | |
12,699 | Rev 09-04-02
TABLETS
ARIMIDEX®
Anastrozole
DESCRIPTION
ARIMIDEX® (anastrozole) tablets for oral administration contain 1 mg of anastrozole, a non-
steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a,
a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is ... | custom-source | 2025-02-12T13:48:15.038934 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20541s10lbl.pdf', 'application_number': 20541, 'submission_type': 'SUPPL ', 'submission_number': 10} |
12,700 | NDA 20-541/S-016
Page 4
09-15-05
ARIMIDEX®
Anastrozole
TABLETS
DESCRIPTION
ARIMIDEX® (anastrozole) tablets for oral administration contain 1 mg of anastrozole, a non-steroidal
aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-
(1H-1,2,4-triazol-1-ylm... | custom-source | 2025-02-12T13:48:15.194730 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020541s016lbl.pdf', 'application_number': 20541, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,702 |
... | custom-source | 2025-02-12T13:48:15.491465 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf', 'application_number': 20541, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,701 |
... | custom-source | 2025-02-12T13:48:15.630267 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf', 'application_number': 20541, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,704 |
... | custom-source | 2025-02-12T13:48:15.820035 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020541s027lbl.pdf', 'application_number': 20541, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,703 |
... | custom-source | 2025-02-12T13:48:15.940097 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf', 'application_number': 20541, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,706 | Population Council
NDA 20-544
"Norplant® II" Levonorgestrel Implants (Jadelle®)
Supplement 003
CONFIDENTIAL
1
JADELLE
levonorgestrel implants
Patients should be counseled that this product does not protect against HIV infection
(AIDS) or other sexually transmitted diseases.
PRESCRIBING INFORMATION
DESCRIPTION
Jadelle... | custom-source | 2025-02-12T13:48:16.107229 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20544se2-003_jadelle_lbl.pdf', 'application_number': 20544, 'submission_type': 'SUPPL ', 'submission_number': 3} |
12,707 |
----------
... | custom-source | 2025-02-12T13:48:16.168498 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020547s027lbl.pdf', 'application_number': 20547, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,705 |
... | custom-source | 2025-02-12T13:48:16.405516 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020541s029lbl.pdf', 'application_number': 20541, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,708 | ACCOLATE
(zafirlukast)
TABLETS
DESCRIPTION
Zafirlukast is a synthetic, selective peptide leukotriene
receptor antagonist (L TRA), with the chemical name 4
(5-cyc1opentyloxy-carbonylamino-l-methyl -indol -3
ylmethy 1)- 3 -methoxy - N -0- to 1 ylsulfonylbenzamide.
The molecular weight of zafirlukast is 575.7 and ... | custom-source | 2025-02-12T13:48:16.580782 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s029lbl.pdf', 'application_number': 20547, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,709 |
ACCOLATE®
(zafirlukast)
TABLETS
DESCRIPTION
Zafirlukast is a synthetic, selective peptide leukotriene
receptor antagonist (LTRA), with the chemical name 4
(5-cyclopentyloxy-carbonylamino-1-methyl-indol-3
ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide.
The molecular weight ... | custom-source | 2025-02-12T13:48:16.630679 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020547s031lbl.pdf', 'application_number': 20547, 'submission_type': 'SUPPL ', 'submission_number': 31} |
12,710 | 1
PRODUCT INFORMATION
1
FLOVENT® 44 mcg
2
(fluticasone propionate, 44 mcg)
3
Inhalation Aerosol
4
5
FLOVENT® 110 mcg
6
(fluticasone propionate, 110 mcg)
7
Inhalation Aerosol
8
9
FLOVENT® 220 mcg
10
(fluticasone propionate, 220 mcg)
11
Inhalation Aerosol
12
13
For Oral Inhalation Only
14
15
DESCRIPTION: The active compo... | custom-source | 2025-02-12T13:48:16.733150 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20548slr019_flovent_lbl.pdf', 'application_number': 20548, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,713 | NDA 20-550/S-005
Page 4
PRESCRIBING INFORMATION
VALTREX®
(valacyclovir hydrochloride)
Caplets
DESCRIPTION
VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of L-valyl ester of the
antiviral drug acyclovir (ZOVIRAX® Brand, GlaxoSmithKline).
VALTREX Caplets are for oral administration. Each... | custom-source | 2025-02-12T13:48:17.017308 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s005lbl.pdf', 'application_number': 20550, 'submission_type': 'SUPPL ', 'submission_number': 5} |
12,712 | 1
PRODUCT INFORMATION
1
FLOVENT® ROTADISK® 50 mcg
2
(fluticasone propionate inhalation powder, 50 mcg)
3
4
FLOVENT® ROTADISK® 100 mcg
5
(fluticasone propionate inhalation powder, 100 mcg)
6
7
FLOVENT® ROTADISK® 250 mcg
8
(fluticasone propionate inhalation powder, 250 mcg)
9
10
For Oral Inhalation Only
11
For Use With t... | custom-source | 2025-02-12T13:48:17.307525 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20549slr014_flovent_lbl.pdf', 'application_number': 20549, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,711 | 1
PRESCRIBING INFORMATION
1
FLOVENT® 44 mcg
2
(fluticasone propionate, 44 mcg)
3
Inhalation Aerosol
4
5
FLOVENT® 110 mcg
6
(fluticasone propionate, 110 mcg)
7
Inhalation Aerosol
8
9
FLOVENT® 220 mcg
10
(fluticasone propionate, 220 mcg)
11
Inhalation Aerosol
12
13
For Oral Inhalation Only... | custom-source | 2025-02-12T13:48:17.308265 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20548slr020,20121slr030_flovent_lbl.pdf', 'application_number': 20548, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,714 | PRODUCT INFORMATION
VALTREX®
(valacyclovir hydrochloride)
Caplets
DESCRIPTION: VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of L-valyl ester of
the antiviral drug acyclovir (ZOVIRAX® Brand, Glaxo Wellcome Inc.).
VALTREX Caplets are for oral administration. Each caplet contains valacyclovir hydrochlori... | custom-source | 2025-02-12T13:48:17.432161 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf', 'application_number': 20550, 'submission_type': 'SUPPL ', 'submission_number': 10} |
12,716 | PRODUCT INFORMATION
VALTREX®
(valacyclovir hydrochloride)
Caplets
DESCRIPTION: VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of L-valyl ester of
the antiviral drug acyclovir (ZOVIRAX® Brand, Glaxo Wellcome Inc.).
VALTREX Caplets are for oral administration. Each caplet contains valacyclovir hydrochlori... | custom-source | 2025-02-12T13:48:17.552196 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf', 'application_number': 20550, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,715 | PRODUCT INFORMATION
VALTREX®
(valacyclovir hydrochloride)
Caplets
DESCRIPTION: VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of L-valyl ester of the antiviral drug
acyclovir (ZOVIRAX® Brand, Glaxo Wellcome Inc.).
VALTREX Caplets are for oral administration. Each caplet contains valacyclovir hydrochlori... | custom-source | 2025-02-12T13:48:17.633106 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s12lbl.pdf', 'application_number': 20550, 'submission_type': 'SUPPL ', 'submission_number': 12} |
12,717 |
----------
NDA 20-552/S-005
Page 3
COVERA-HS - verapamil hydrochloride tablet, extended release
G.D. Searle LLC
COVERA-HS®
(verapamil hydrochloride)
Extended-Release Tablets
Controlled-Onset
DESCRIPTION
COVERA-HS (verapamil hydrochloride) is a calcium ion influx inhibitor (slow-ch... | custom-source | 2025-02-12T13:48:17.696976 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020552s005lbl.pdf', 'application_number': 20552, 'submission_type': 'SUPPL ', 'submission_number': 5} |
12,718 |
COVERA-HS®
(verapamil hydrochloride)
Extended-Release Tablets
Controlled-Onset
DESCRIPTION
COVERA-HS (verapamil hydrochloride) is a calcium ion influx inhibitor (slow-channel
blocker or calcium ion antagonist). COVERA-HS is available for oral administration as
pale yellow, round, film-c... | custom-source | 2025-02-12T13:48:17.973015 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020552s007lbl.pdf', 'application_number': 20552, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,719 | custom-source | 2025-02-12T13:48:17.980164 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20555-S3_AxidAr_prntlbl.pdf', 'application_number': 20555, 'submission_type': 'SUPPL ', 'submission_number': 4} | |
12,721 | 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 | 2025-02-12T13:48:18.012469 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20560s21s22lbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,722 |
Patient Information
FOSAMAX® (alendronate sodium) Tablets
Read this information before you start taking FOSAMAX* (FOSS-ah-max). Also, read the leaflet each time
you refill your prescription, just in case anything has changed. This leaflet does not take the place of
discussions with your doctor. You and your... | custom-source | 2025-02-12T13:48:18.298545 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr030,21575slr002_fosamax_lbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,723 |
7957024
FOSAMAX®
(ALENDRONATE SODIUM) TABLETS AND ORAL SOLUTION
DESCRIPTION
FOSAMAX* (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-
mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the
hydroxyapatite found in bone.
Ale... | custom-source | 2025-02-12T13:48:18.437752 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560se8-041,21575slr004_fosamax_lbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 41} |
12,720 | BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY
APPEARS THIS WAY ON ORIGINAL
BEST POSSIBLE COPY
BEST POSSIBLE COPY
BEST POSSIBLE COPY... | custom-source | 2025-02-12T13:48:18.494795 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax_prntlbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,724 |
7957023
FOSAMAX®
(ALENDRONATE SODIUM) TABLETS AND ORAL SOLUTION
DESCRIPTION
FOSAMAX* (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-
mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the
hydroxyapatite found in bone... | custom-source | 2025-02-12T13:48:18.497385 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fosamax_lbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 42} |
12,725 |
79570XX
FOSAMAX®
(ALENDRONATE SODIUM) TABLETS AND ORAL SOLUTION
DESCRIPTION
FOSAMAX* (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-
mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the
hydroxyapatite found in bone. ... | custom-source | 2025-02-12T13:48:18.714666 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 43} |
12,726 | FOSAMAX®
(ALENDRONATE SODIUM)
TABLETS AND ORAL SOLUTION
DESCRIPTION
FOSAMAX* (alendronate sodium) is a bisphosphonate that acts as a specific
inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic
analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
Alendronate sodium is chem... | custom-source | 2025-02-12T13:48:19.620544 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021575s009,020560s046lbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 46} |
12,728 |
Company logo
9635610
9636810
FOSAMAX®
(ALENDRONATE SODIUM) TABLETS AND ORAL SOLUTION
DESCRIPTION
FOSAMAX* (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-
mediated bone resorptio... | custom-source | 2025-02-12T13:48:19.703845 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 51} |
12,729 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FOSAMAX safely and effectively. See full prescribing information
for FOSAMAX.
FOSAMAX
® (alendronate sodium) ... | custom-source | 2025-02-12T13:48:19.994621 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s056lbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 56} |
12,727 |
9635604
9636804
FOSAMAX®
(ALENDRONATE SODIUM) TABLETS AND ORAL SOLUTION
DESCRIPTION
FOSAMAX* (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-
mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the
hydroxyapatite foun... | custom-source | 2025-02-12T13:48:20.139859 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 48} |
12,733 | Humalog Lispro
Exp. Date/Control No.
WG 3550 AMX
10 mL VL-7510
100 units per mL
(rDNA origin)
insulin lispro injection
®
x
P
U-100
CAUTION–Federal (USA) law prohibits
dispensing without a prescription.
For parenteral use.
See accompanying literature for dosage.
Neutral
Eli Lilly and Company, Indianapolis, IN 46... | custom-source | 2025-02-12T13:48:20.232307 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr015_humalog_lbl.pdf', 'application_number': 20563, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,734 | NDA 20-563/S-024
Page 1
1
Lilly’s submission date: May 24, 2004
A2.0 NL 3690 AMP
1
HUMALOG
®
2
INSULIN LISPRO INJECTION
3
(rDNA ORIGIN)
4
100 UNITS PER ML (U-100)
5
DESCRIPTION
6
Humalog® (insulin lispro, rDNA origin) is a human insulin analog that is a rapid-acting,
7
parenteral blood glucose-lo... | custom-source | 2025-02-12T13:48:20.618334 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563se3-024_humalog_lbl.pdf', 'application_number': 20563, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,737 |
1
5.01 PA 9155 FSAMP
1
INFORMATION FOR THE PATIENT
2
3 ML DISPOSABLE INSULIN DELIVERY DEVICE
3
HUMALOG® Pen
4
INSULIN LISPRO INJECTION
5
(rDNA ORIGIN)
6
100 UNITS PER ML (U-100)
7
WARNINGS
8
THIS LILLY HUMAN INSULIN ANALOG IS DIFFERENT FROM OTHER
9
INSULINS BECAUSE IT HAS A RAPID ONSET AND SHORTE... | custom-source | 2025-02-12T13:48:20.865736 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr046_humalog_lbl.pdf', 'application_number': 20563, 'submission_type': 'SUPPL ', 'submission_number': 46} |
12,730 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FOSAMAX safely and effectively. See full prescribing information
for FOSAMAX.
FOSAMAX
® (alendr... | custom-source | 2025-02-12T13:48:21.387357 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s065,021575s022lbl.pdf', 'application_number': 20560, 'submission_type': 'SUPPL ', 'submission_number': 65} |
12,735 | 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 | 2025-02-12T13:48:21.477976 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf', 'application_number': 20563, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,739 |
1
PA 9350 FSAMP
HUMALOG®
INSULIN LISPRO INJECTION
(rDNA ORIGIN)
100 UNITS PER ML (U-100)
DESCRIPTION
Humalog® (insulin lispro, rDNA origin) is a human insulin analog that is a rapid-acting,
parenteral blood glucose-lowering agent. Chemically, it is Lys(B28), Pro(B29) human insulin
analog, created when the am... | custom-source | 2025-02-12T13:48:21.639425 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s076lbl.pdf', 'application_number': 20563, 'submission_type': 'SUPPL ', 'submission_number': 76} |
12,738 |
1
AAD_0025 NL 5532 AMP
1
HUMALOG®
2
INSULIN LISPRO INJECTION, USP
3
(rDNA ORIGIN)
4
100 UNITS PER ML (U-100)
5
DESCRIPTION
6
Humalog® [insulin lispro injection, USP (rDNA origin)] is a human insulin analog that is a
7
rapid-acting, parenteral blood glucose-lowering agent. Chemically, it is Lys(B28), Pr... | custom-source | 2025-02-12T13:48:21.974511 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf', 'application_number': 20563, 'submission_type': 'SUPPL ', 'submission_number': 75} |
12,740 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
HUMALOG safely and effectively. See full prescribing information for
HUMALOG.
H... | custom-source | 2025-02-12T13:48:22.371636 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf', 'application_number': 20563, 'submission_type': 'SUPPL ', 'submission_number': 105} |
12,745 |
PRESCRIBING INFORMATION
EPIVIR® Tablets
(lamivudine tablets)
EPIVIR® Oral Solution
(lamivudine oral solution)
WARNING
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE
ANALOGUES ALONE OR IN COMBINATION, INCLUDING LAMIVUDINE AND... | custom-source | 2025-02-12T13:48:22.587871 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s14,20596s15lbl.pdf', 'application_number': 20564, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,746 | NDA 20-564/S-015
NDA 20-596/S-016
Page 4
PRODUCT INFORMATION
EPIVIR® Tablets
(lamivudine tablets)
EPIVIR® Oral Solution
(lamivudine oral solution)
WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE
ANALOGUES ALONE OR IN... | custom-source | 2025-02-12T13:48:22.602782 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20564s015and20596s016lbl.pdf', 'application_number': 20564, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,747 | WARNING
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES,
HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION,
INCLUDING LAMIVUDINE AND OTHER ANTIRETROVIRALS (SEE WARNINGS).
EPIVIR TABLETS AND ORAL SOLUTION (USED TO TREAT HIV INFECTION) CONTAIN A HIGHER
DOSE OF T... | custom-source | 2025-02-12T13:48:23.051795 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20596slr020,20564slr019_epivir_lbl.pdf', 'application_number': 20564, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,741 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
HUMALOG safely and effectively. See full prescribing information for
HUMALOG.
H... | custom-source | 2025-02-12T13:48:23.311428 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s117lbl.pdf', 'application_number': 20563, 'submission_type': 'SUPPL ', 'submission_number': 117} |
12,748 | 1
PRESCRIBING INFORMATION
EPIVIR® Tablets
(lamivudine tablets)
EPIVIR® Oral Solution
(lamivudine oral solution)
WARNING
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF
NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING
LAMIVUDINE AND... | custom-source | 2025-02-12T13:48:23.402570 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20596s021,20564s020lbl.pdf', 'application_number': 20564, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,749 | CAMPTOSAR
sNDA 20-571/S008
Page 1
For Intravenous Use Only
1
WARNINGS
2
3
CAMPTOSAR Injection should be administered only under the supervision of a physician who is
4
experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is
5
possible only when adequate diagnostic and treatm... | custom-source | 2025-02-12T13:48:23.578046 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20571s8lbl.pdf', 'application_number': 20571, 'submission_type': 'SUPPL ', 'submission_number': 8} |
12,751 | NDA 20-571
UGT1A1
Camptosar®(irinotecan HCl)
Final Label
Camptosar®
irinotecan hydrochloride injection
For Intravenous Use Only
WARNINGS
CAMPTOSAR Injection should be administered only under the supervision of a
physician who is experienced in the use of cancer chemotherapeutic agents. Appropriate
manag... | custom-source | 2025-02-12T13:48:24.112845 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s026lbl.pdf', 'application_number': 20571, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,753 |
Camptosar®
irinotecan hydrochloride injection
For Intravenous Use Only
WARNINGS
CAMPTOSAR Injection should be administered only under the supervision of a
physician who is experienced in the use of cancer chemotherapeutic agents. Appropriate
management of complica... | custom-source | 2025-02-12T13:48:24.321885 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf', 'application_number': 20571, 'submission_type': 'SUPPL ', 'submission_number': 31} |
12,750 |
1
CAMPTOSAR®
1
irinotecan hydrochloride injection
2
3
WARNINGS
4
CAMPTOSAR Injection should be administered only under the supervision of a
5
physician who is experienced in the use of cancer chemotherapeutic agents. Appropriate
6
management of complications is possible only when adequate diagnostic ... | custom-source | 2025-02-12T13:48:24.484747 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20571s16lbl.pdf', 'application_number': 20571, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,752 | NDA 20-571/S-024/S-027/S-028
Hepatic Dysfunction, Pancreatitis, UGT1A1
Camptosar®(irinotecan HCl)
July 21, 2005, Final Label
Page 1
Camptosar®
irinotecan hydrochloride injection
For Intravenous Use Only
WARNINGS
CAMPTOSAR Injection should be administered only under the supervision of a
physician who... | custom-source | 2025-02-12T13:48:24.865566 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf', 'application_number': 20571, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,754 |
Camptosar®
irinotecan hydrochloride injection
For Intravenous Use Only
WARNINGS
CAMPTOSAR Injection should be administered only under the supervision of a
physician who is experienced in the use of cancer chemotherapeutic agents. Appropriate
management of complica... | custom-source | 2025-02-12T13:48:24.921828 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf', 'application_number': 20571, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,755 |
Camptosar®
irinotecan hydrochloride injection
For Intravenous Use Only
WARNINGS
CAMPTOSAR Injection should be administered only under the supervision of a
physician who is experienced in the use of cancer chemotherapeutic agents. Appropriate
management of complica... | custom-source | 2025-02-12T13:48:25.140083 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf', 'application_number': 20571, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,757 |
BUPHENYL® (sodium phenylbutyrate) Tablets
BUPHENYL® (sodium phenylbutyrate) Powder
[bu’fen-əl]
(sodium phenylbutyrate)
Rx Only
DESCRIPTION
BUPHENYL® (sodium phenylbutyrate) Tablets for oral administration and BUPHENYL® (sodium
phenylbutyrate) Powder for oral, nasogastric, o... | custom-source | 2025-02-12T13:48:25.400661 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.pdf', 'application_number': 20572, 'submission_type': 'SUPPL ', 'submission_number': 16} |
12,756 |
... | custom-source | 2025-02-12T13:48:25.462164 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf', 'application_number': 20571, 'submission_type': 'SUPPL ', 'submission_number': 48} |
12,758 |
BUPHENYL® (sodium phenylbutyrate) Tablets
BUPHENYL® (sodium phenylbutyrate) Powder
[bu’fen-əl]
(sodium phenylbutyrate)
Rx Only
DESCRIPTION
BUPHENYL® (sodium phenylbutyrate) Tablets for oral administration and BUPHENYL® (sodium
phenylbutyrate) Powder for oral, nasogastric, o... | custom-source | 2025-02-12T13:48:25.485300 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020572s016,020573s015lbl.pdf', 'application_number': 20573, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,759 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:48:25.540287 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020576s010lbl.pdf', 'application_number': 20576, 'submission_type': 'SUPPL ', 'submission_number': 10} |
12,763 |
_____________________________________________________________________________________
... | custom-source | 2025-02-12T13:48:25.829412 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf', 'application_number': 20578, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,761 |
_______________________________________________________________________________
... | custom-source | 2025-02-12T13:48:25.922597 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf', 'application_number': 20578, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,762 |
NDA 020578/S-032
Zoladex (goserelin acetate
implant) 10.8 mg
Reference ID: 2888048
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
... | custom-source | 2025-02-12T13:48:25.998232 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020578s032lbl.pdf', 'application_number': 20578, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,764 |
_____________________________________________________________________________________
... | custom-source | 2025-02-12T13:48:26.142830 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf', 'application_number': 20578, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,765 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZOLADEX safely and effectively. See full prescribing information for
ZOLADEX.
ZOLADEX® (goserelin acetate implant) 3.6 mg
Initial U.S. Approval: 1989
-------------------------- RECENT MAJOR CHANGES ------... | custom-source | 2025-02-12T13:48:26.486269 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.pdf', 'application_number': 20578, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,766 | Flomax®
(tamsulosin hydrochloride)
Capsules, 0.4 mg
Prescribing Information
DESCRIPTION
Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.
Tamsulosin hydrochloride is (-)-(R)-5-[2-[[2-(o-Ethoxyphenoxy) ethyl]amino]propyl]-2-
methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hy... | custom-source | 2025-02-12T13:48:26.736797 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s020lbl.pdf', 'application_number': 20579, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,767 | ATTENTION PHARMACIST: Detach “Patient Information” from package insert and
dispense with product.
Flomax®
(tamsulosin hydrochloride)
Capsules, 0.4 mg
Rx only
Prescribing Information
DESCRIPTION
Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate.
Tamsulosin hydrochlor... | custom-source | 2025-02-12T13:48:26.741043 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s021lbl.pdf', 'application_number': 20579, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,760 | 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 | 2025-02-12T13:48:26.754918 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf', 'application_number': 20578, 'submission_type': 'SUPPL ', 'submission_number': 3} |
12,769 |
_______________________________________________________________________________________________________________________________________ ... | custom-source | 2025-02-12T13:48:27.052942 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s026lbl.pdf', 'application_number': 20579, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,768 |
ATTENTION PHARMACIST: Detach “Patient Information” from package insert and
dispense with the product. Company logo
Flomax®
(tamsulosin hydrochloride)
Capsules, 0.4 mg
Rx only
Prescribing Information
DESCRIPTION
Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the pros... | custom-source | 2025-02-12T13:48:27.140108 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s025lbl.pdf', 'application_number': 20579, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,771 |
Follistim
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
(follitropin beta for injection)
FOR SUBCUTANEOUS OR INTRAMUSCULAR USE ONLY
DESCRIPTION
Follistim (follitropin beta for... | custom-source | 2025-02-12T13:48:27.232699 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20582s006lbl.pdf', 'application_number': 20582, 'submission_type': 'SUPPL ', 'submission_number': 6} |
12,773 | NDA 20-584/S-004, S-006, S-007
Page 3
Lodine XL
(etodolac extended-release tablets)
400 mg, 500 mg, 600 mg
] only
DESCRIPTION
Lodine XL (etodolac extended-release tablets) contains etodolac, which is a member of the
pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet... | custom-source | 2025-02-12T13:48:27.566261 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020584s004,006,007lbl.pdf', 'application_number': 20584, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,770 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:48:27.719757 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020579s027lbl.pdf', 'application_number': 20579, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,774 | 1
JANSSEN
PHARMACEUTICA
PRODUCTS, L.P.
RISPERDAL®
(RISPERIDONE)
TABLETS/ORAL SOLUTION
RISPERDAL® M-TAB™
(RISPERIDONE)
ORALLY DISINTEGRATING TABLETS
DESCRIPTION
RISPERDAL® (risperidone) is a psychotropic agent belonging to the chemical class of
benzisoxazole
derivatives.
The
chemical
designatio... | custom-source | 2025-02-12T13:48:27.787184 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf', 'application_number': 20588, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,775 | NDA 20-272 / S-036, 20-588 / S-024, 21-444 / S-008: Final Agreed-Upon Labeling
1
JANSSEN, L.P.
RISPERDAL®
(risperidone)
TABLETS/ORAL SOLUTION
RISPERDAL® M-TAB®
(risperidone)
ORALLY DISINTEGRATING TABLETS
Increased Mortality in Elderly Patients with Dementia –Related Psychosis
Elderly patients with dem... | custom-source | 2025-02-12T13:48:28.078622 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf', 'application_number': 20588, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,772 | custom-source | 2025-02-12T13:48:28.090865 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-584S005_Lodine_prntlbl.pdf', 'application_number': 20584, 'submission_type': 'SUPPL ', 'submission_number': 5} | |
12,778 |
HIGHLIGHTS OF... | custom-source | 2025-02-12T13:48:28.726378 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf', 'application_number': 20588, 'submission_type': 'SUPPL ', 'submission_number': 44} |
12,777 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® safely and effectively. See full prescribing information for
RISPERDAL®.
RISPERDAL® (risperidone) tablets, RISPERDAL® (risperidone) oral
solution, RISPERDAL® M-TAB® (risperidone) orally d... | custom-source | 2025-02-12T13:48:29.321115 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf', 'application_number': 20588, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,776 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® safely and effectively. See full prescribing information for
RISPERDAL®.
RISPERDAL® (risperidone) tablets, RISPERDAL® (risperidone) oral
solution, RISPERDAL® M-TAB® (risperidone) orally d... | custom-source | 2025-02-12T13:48:29.365857 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf', 'application_number': 20588, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,779 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the... | custom-source | 2025-02-12T13:48:29.560725 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf', 'application_number': 20588, 'submission_type': 'SUPPL ', 'submission_number': 47} |
12,780 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® safely and effectively. See full prescribing information for
RISPERDAL®.
RISPERDAL® (risperidone) tablets, RISPERDAL® (risperidone) oral
solution, RISPERDAL® M-TAB® (risperidone) orally disintegratin... | custom-source | 2025-02-12T13:48:29.768885 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf', 'application_number': 20588, 'submission_type': 'SUPPL ', 'submission_number': 50} |
12,782 |
HIGHLIGHTS OF ... | custom-source | 2025-02-12T13:48:30.488664 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf', 'application_number': 20588, 'submission_type': 'SUPPL ', 'submission_number': 54} |
12,785 | 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 | 2025-02-12T13:48:31.332825 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020589Orig1s029lbl_edt.pdf', 'application_number': 20589, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,784 | 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 | 2025-02-12T13:48:31.382366 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20589s13lbl.pdf', 'application_number': 20589, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,783 |
HIGHLIGHTS ... | custom-source | 2025-02-12T13:48:31.513819 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf', 'application_number': 20588, 'submission_type': 'SUPPL ', 'submission_number': 62} |
12,781 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the inf... | custom-source | 2025-02-12T13:48:31.923846 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf', 'application_number': 20588, 'submission_type': 'SUPPL ', 'submission_number': 51} |
12,787 |
MAVIK®
(trandolapril tablets)
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue MAVIK as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing
fetus (See WARNINGS: Fetal Toxicity).
DESCRIPTION
Trandolapril is the ethy... | custom-source | 2025-02-12T13:48:32.100514 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020528s020,020591s020lbl.pdf', 'application_number': 20591, 'submission_type': 'SUPPL ', 'submission_number': 20} |
12,788 |
TARKA®
(trandolapril/verapamil hydrochloride ER tablets)
WARNING: FETAL TOXICITY
• When pregnancy is detected, discontinue TARKA as soon as possible.
• Drugs that act directly on the renin-angiotensi... | custom-source | 2025-02-12T13:48:32.221758 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020591s025lbl.pdf', 'application_number': 20591, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,786 |
TARKA®
(trandolapril/verapamil hydrochloride ER tablets)
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and
even death to the developing fetus. When pregnancy is detected, TARKA should be discontinued as soon as
possible. See WARNINGS - Fet... | custom-source | 2025-02-12T13:48:32.418371 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020591s012lbl.pdf', 'application_number': 20591, 'submission_type': 'SUPPL ', 'submission_number': 12} |
12,790 |
APPROVED AGREED-UPON LABELING
1
ZYPREXA®
1
(Olanzapine) Tablets
2
3
ZYPREXA® ZYDIS®
4
(Olanzapine) Orally Disintegrating Tablets
5
DESCRIPTION
6
ZYPREXA (olanzapine) is a psychotropic agent that belongs to the thienobenzodiazepine class.
7
The chemical designation is 2-methyl-4-(4-methyl-1-piper... | custom-source | 2025-02-12T13:48:32.652178 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20592se1-019_zyprexa_lbl.pdf', 'application_number': 20592, 'submission_type': 'SUPPL ', 'submission_number': 19} |
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