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[email protected]: FDA-Approved Drugs

* 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 …

Actived: 3 days ago

URL: accessdata.fda.gov


[email protected]: FDA-Approved Drugs

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

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[email protected]: FDA-Approved Drugs

(2 days ago) telmisartan. telmisartan (telmisartan) | anda #202130 | tablet;oral | alembic pharms ltd telmisartan (telmisartan) | anda #204415 | tablet;oral | amneal pharms

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[email protected]: FDA-Approved Drugs

(5 days ago) 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.

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[email protected]: FDA-Approved Drugs

(2 days ago) 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 | …

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[email protected]: FDA-Approved Drugs

(8 days ago) 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

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[email protected]: FDA-Approved Drugs

(2 days ago) lamivudine/tenofovir disoproxil fumarate fdc tabs (lamivudine; tenofovir) | nda #022459 | tablet; oral | hetero drugs ltd Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 09/27/2021: SUPPL-25: Labeling-Package Insert

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[email protected]: FDA-Approved Drugs

(2 days ago) 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) …

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 04/01/2021: SUPPL-30: Supplement

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[email protected]: FDA-Approved Drugs

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

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[email protected]: FDA-Approved Drugs

(2 days ago) 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

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[email protected]: FDA-Approved Drugs

(2 days ago) 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

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[email protected]: FDA-Approved Drugs

(8 days ago) 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, Labeling-Package Insert

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[email protected]: FDA-Approved Drugs

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

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 10/23/2020: SUPPL-16: …

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 07/09/2021: SUPPL-35: Labeling-Package Insert

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 11/17/2021: SUPPL-14: Labeling-Package Insert

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 04/10/2020: SUPPL-8: Efficacy-New Indication

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[email protected]: FDA-Approved Drugs

(2 days ago) 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) | …

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 03/23/2021: ORIG-1: Approval Label (PDF)

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[email protected]: FDA-Approved Drugs

(3 days ago) cabergoline. cabergoline (cabergoline) | anda #204735 | tablet;oral | ingenus pharms llc cabergoline (cabergoline) | anda #201503 | tablet;oral | apotex corp

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[email protected]: FDA-Approved Drugs

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

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[email protected]: FDA-Approved Drugs

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

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[email protected]: FDA-Approved Drugs

(1 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 01/19/2021: ORIG-1: Approval Label (PDF)

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[email protected]: FDA-Approved Drugs

(2 days ago) 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 | …

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 08/04/2021: SUPPL-8: Labeling-Package Insert, Labeling-Container/Carton Labels

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 10/24/2019: SUPPL-7: Efficacy-New Indication

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[email protected]: FDA-Approved Drugs

(1 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 02/12/2021: ORIG-1: Approval Label (PDF)

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[email protected]: FDA-Approved Drugs

(1 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 04/02/2021: ORIG-1: Approval Label (PDF)

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[email protected]: FDA-Approved Drugs

(1 days ago) Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; CABENUVA KIT: CABOTEGRAVIR; RILPIVIRINE: …

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Drug Approval Package: KERENDIA

(8 days ago) 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.

Category:  Pharmaceutical,  Health Go Now


[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 11/04/2021: SUPPL-46: Labeling-Package Insert

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[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 09/02/2021: SUPPL-11: Labeling-Package Insert

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[email protected]: FDA-Approved Drugs

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

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[email protected]: FDA-Approved Drugs

(1 days ago) Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; RYLAZE: ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN: 10MG/0.5ML

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[email protected]: FDA-Approved Drugs

(2 days ago) 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 …

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[email protected]: FDA-Approved Drugs

(8 days ago) 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 …

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Medication Guides

(7 days ago) 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

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[email protected]: FDA-Approved Drugs

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

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Drug Approval Package: QELBREE

(8 days ago) Drug Approval Package: QELBREE. Company: Supernus Pharmaceuticals, Inc. Application Number: 211964. Approval Date: 4/2/2021. Drugs@FDA information available about QELBREE. Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling.

Category:  Pharmaceutical Go Now


[email protected]: FDA-Approved Drugs

(8 days ago) Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 02/27/2017: SUPPL-39: Labeling

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