Accessdata.fda.gov View all drugs

[email protected]: FDA-Approved Drugs

Details: * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).

› Verified 3 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process Go Now

• Get more: Fda accessdata searchGo Now

[email protected]: FDA-Approved Drugs

Details: U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

› Verified 5 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process Go Now

• Get more: Fda approval databaseGo Now

[email protected]: FDA-Approved Drugs

Details: This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly " All Approvals " report on Drugs@FDA.

› Verified 5 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page Go Now

• Get more: Fda device databaseGo Now

[email protected]: FDA-Approved Drugs

Details: telmisartan. telmisartan (telmisartan) | anda #202130 | tablet;oral | alembic pharms ltd telmisartan (telmisartan) | anda #204415 | tablet;oral | amneal pharms

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=T&ai=0 Go Now

• Get more: Access fda dataGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 05/31/2021: SUPPL-12: Efficacy-New Patient Population

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205053 Go Now

• Get more: Fda drug approvalsGo Now

[email protected]: FDA-Approved Drugs

Details: lamivudine/tenofovir disoproxil fumarate fdc tabs (lamivudine; tenofovir) | nda #022459 | tablet; oral | hetero drugs ltd Lamivudine/Zidovudine 150 mg/300 mg Tablets Co …

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=L&ai=0 Go Now

• Get more: Fda medical devicesGo Now

[email protected]: FDA-Approved Drugs

Details: valacyclovir hydrochloride. valacyclovir hydrochloride (valacyclovir hydrochloride) | anda #076588 | tablet;oral | sun pharm inds ltd valacyclovir hydrochloride (valacyclovir hydrochloride) | anda #077478 | tablet;oral | sandoz valacyclovir hydrochloride (valacyclovir hydrochloride) | anda #077135 | tablet;oral | cipla valacyclovir hydrochloride (valacyclovir hydrochloride) | anda #077655

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=V&ai=0 Go Now

• Get more: Database of fda approved drugsGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 12/03/2020: ORIG-1: Approval Label (PDF)

› Verified 1 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214094 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; CABENUVA KIT: CABOTEGRAVIR; RILPIVIRINE: 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)

› Verified 1 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212888 Go Now

› Get more:  DoctorGo Now

Drug Approval Package: KERENDIA

Details: Drug Approval Package: KERENDIA. Company: Bayer HealthCare Pharmaceuticals, Inc. Application Number: 215341. Approval Date: 7/9//2021. Drugs@FDA information available about KERENDIA. Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling.

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215341Orig1s000TOC.cfm Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 02/01/2021: ORIG-1: Approval Label (PDF)

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204803 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: a-hydrocort. a-hydrocort (hydrocortisone sodium succinate) | anda #040666 | injectable;injection | hospira a-hydrocort (hydrocortisone sodium succinate) | anda #085928 | injectable;injection | abbott a-hydrocort (hydrocortisone sodium succinate) | anda #085929 | injectable;injection | hospira a-hydrocort (hydrocortisone sodium succinate) | anda #085930 | injectable;injection | hospira

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=A&ai=0 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 11/06/2020: SUPPL-25: Labeling-Package Insert

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021361 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 10/23/2020: SUPPL-16: Efficacy-Labeling Change With Clinical Data

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203415 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: cabergoline. cabergoline (cabergoline) | anda #204735 | tablet;oral | ingenus pharms llc cabergoline (cabergoline) | anda #201503 | tablet;oral | apotex corp

› Verified 3 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=C Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 10/22/2021: ORIG-1: Approval Label (PDF)

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211950 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: enalapril maleate. enalapril maleate (enalapril maleate) | anda #075048 | tablet;oral | sandoz enalapril maleate (enalapril maleate) | anda #075178 | tablet;oral | nostrum labs inc enalapril maleate (enalapril maleate) | anda #075369 | tablet;oral | krka dd novo mesto enalapril maleate (enalapril maleate) | anda #075370 | tablet;oral | krka dd novo mesto

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=E&ai=0 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; ADUHELM: ADUCANUMAB-AVWA: 170MG/1.7ML (100MG/ML) INJECTABLE;INJECTION

› Verified 1 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761178 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 10/28/2021: SUPPL-10: Efficacy-Labeling Change With Clinical Data

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208743 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: pamidronate disodium. pamidronate disodium (pamidronate disodium) | nda #021113 | injectable;injection | hikma pamidronate disodium (pamidronate disodium) | anda #077703 | injectable;injection | sun pharma global pamidronate disodium (pamidronate disodium) | anda #077433 | injectable;injection | areva pharms pamidronate disodium (pamidronate disodium) | anda #078156 | injectable;injection | dr

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=P&ai=0 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: famotidine preservative free. famotidine preservative free (famotidine) | anda #075813 | injectable;injection | fresenius kabi usa famotidine preservative free (famotidine) | anda #075825 | injectable;injection | athenex inc famotidine preservative free (famotidine) | anda #075708 | injectable;injection | apothecon famotidine preservative free (famotidine) | anda #075669 | …

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=F&ai=0 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 01/26/2018: SUPPL-2: Efficacy-Labeling Change With Clinical Data

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206192 Go Now

› Get more:  DoctorGo Now

Medication Guides

Details: Medication guides are FDA- approved documents that address issues that are specific to particular drugs, and can help patients avoid serious adverse events (side effects). This database does not include Medication Guides for FDA-approved allergenic or cellular/tissue products (see FDA Online Label Repository or DailyMed for these Medication

› Verified 7 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=medguide.page Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 04/22/2021: SUPPL-8: Labeling-Package Insert

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207500 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Prescription. Yes. AB. 021654. WOODWARD. OMEGA-3-ACID ETHYL ESTERS. OMEGA-3-ACID ETHYL ESTERS. 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS. CAPSULE;ORAL.

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=090973 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: raloxifene hydrochloride. raloxifene hydrochloride (raloxifene hydrochloride) | anda #200825 | tablet;oral | watson labs inc raloxifene hydrochloride (raloxifene hydrochloride) | anda #206384 | tablet;oral | sciegen pharms inc raloxifene hydrochloride (raloxifene hydrochloride) | anda #204310 | tablet;oral | aurobindo pharma ltd raloxifene hydrochloride (raloxifene hydrochloride) | anda

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=R&ai=0 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 05/28/2020: SUPPL-13: Labeling-Container/Carton Labels, …

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201699 Go Now

› Get more:  DoctorGo Now

TRAZODONE hydrochloride Label

Details: drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences

› Verified 5 days ago

› Url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 05/28/2021: SUPPL-43: Efficacy-New Indication

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125504 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; CELESTONE: BETAMETHASONE SODIUM PHOSPHATE: EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017561 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 08/20/2018: ORIG-1: Approval Label (PDF)

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206709 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Approval Date (s) and History, Letters, Labels, Reviews for NDA 213498. Original Approvals or Tentative Approvals. CSV Excel Print.

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213498 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: bendamustine hydrochloride. bendamustine hydrochloride (bendamustine hydrochloride) | nda #212209 | injectable;injection | slayback pharma llc bendamustine hydrochloride (bendamustine hydrochloride) | anda #210410 | solution;iv (infusion) | fresenius kabi usa bendamustine hydrochloride (bendamustine hydrochloride) | anda #206554 | powder;iv (infusion) | nang kuang pharm co

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=B&ai=0 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

› Verified 9 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process&rptName=1&reportSelectMonth=9&reportSelectYear=2021 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 03/15/2021: SUPPL-10: Labeling-Package Insert

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209176 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 12/15/2020: SUPPL-16: Labeling-Package Insert

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022206 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 01/16/2020: SUPPL-124: Efficacy-Labeling Change With Clinical Data

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125409 Go Now

› Get more:  DoctorGo Now

Drug Approval Package: Aduhelm (aducanumab-avwa)

Details: Drug Approval Package: Aduhelm (aducanumab-avwa) Company: Biogen, Inc. Application Number: 761178. Approval Date: 06/07/2021. Drugs@FDA information available about Aduhelm (aducanumab-avwa) Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling.

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761178Orig1s000TOC.cfm Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; XOPENEX HFA: LEVALBUTEROL TARTRATE: EQ 0.045MG BASE/INH: AEROSOL, METERED;INHALATION

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021730 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 08/25/2021: ORIG-1: Approval Label (PDF)

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761177 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 08/04/2021: SUPPL-8: Labeling …

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206143 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 10/15/2019: SUPPL-100: Labeling-Package Insert

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125388 Go Now

› Get more:  DoctorGo Now

What Is an OTC Drug

Details: There are hundreds of OTC drugs at your local pharmacy. Many items you may think are cosmetics, dietary supplements, or medical devices, which have their own regulatory requirements, may also be classified as "drugs." The term "drug" is a legal one. As described in …

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/training/OTC/topic2/topic2/da_01_02_0030.htm Go Now

› Get more:  MedicalGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 11/30/2017: SUPPL-22: Labeling-Package Insert

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021742 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER. SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER (POTASSIUM CHLORIDE; SODIUM CHLORIDE) | NDA #018722 | INJECTABLE;INJECTION | B BRAUN. SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER.

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=S&ai=0 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: octreotide acetate. octreotide acetate (octreotide acetate) | anda #075957 | injectable;injection | teva pharms usa octreotide acetate (octreotide acetate) | anda #075959 | injectable;injection | teva pharms usa octreotide acetate (octreotide acetate) | anda #076330 | injectable;injection | west-ward pharms int octreotide acetate (octreotide acetate) | anda #077329 | injectable;injection | sun

› Verified 2 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=O&ai=0 Go Now

› Get more:  DoctorGo Now

[email protected]: FDA-Approved Drugs

Details: Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 11/10/2020: SUPPL-5: Labeling-Medication Guide

› Verified 8 days ago

› Url: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761049 Go Now

› Get more:  DoctorGo Now

Related topics