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FDA-Approved Drugs Directory

US FDA-approved and listed pharmaceutical products with Drugs@FDA-derived regulatory status, brand names, and pipeline cross-links.

Quick answer

FDA-approved drugs: NovaPharmaNews tracks 2,719 pharmaceutical drugs in this segment. US FDA-approved and listed pharmaceutical products with Drugs@FDA-derived regulatory status, brand names, and pipeline cross-links.

2,719 drugs · FDA approved · by data quality · Page 4 of 114

  1. azelaic acid

    AZELAIC ACID Almirall, S.A.

    TOPICAL FDA: approved

  2. azelastine hydrochloride

    DYMISTA Amneal Pharma Europe Ltd

    OPHTHALMIC FDA: approved

  3. azilsartan medoxomil

    EDARBI Takeda

    FDA: approved · EMA: approved

    C09CA09

  4. azithromycin

    APO-AZITHROMYCIN Pfizer Australia Pty Ltd

    OPHTHALMIC FDA: approved · TGA: approved · NMPA: clinical trials

  5. baclofen

    APO-BACLOFEN Alphapharm Pty Ltd

    INTRATHECAL FDA: approved · TGA: approved

  6. beclomethasone dipropionate

    ORBEC Amneal Pharma Europe Ltd

    NASAL FDA: approved · EMA: application withdrawn

  7. bempedoic acid

    NILEMDO Esperion Therapeutics

    ORAL FDA: approved · EMA: approved

    C10B

  8. benazepril hydrochloride

    BENAZEPRIL HYDROCHLORIDE Amneal Pharma Europe Ltd

    ORAL FDA: approved

  9. benzgalantamine gluconate

    ZUNVEYL COGNITION THERAPEUTICS INC

    ORAL FDA: approved

  10. benztropine mesylate

    BENZTROPINE MESYLATE Quantum Biopharma

    INJECTION FDA: approved

  11. berotralstat dihydrochloride

    ORLADEYO Biocryst

    ORAL FDA: approved

  12. betaine

    CYSTADANE Recordati Rare Diseases Australia Pty.

    ORAL FDA: approved · TGA: approved

  13. betamethasone acetate

    BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE Regeneron Ireland Designated Activity Company (DAC)

    INJECTION FDA: approved

  14. betamethasone dipropionate

    DIPROSONE Alphapharm Pty Ltd

    TOPICAL FDA: approved · TGA: approved

  15. betamethasone valerate

    ANTROQUORIL Alphapharm Pty Ltd

    TOPICAL FDA: approved · TGA: approved

  16. bethanechol chloride

    MYOTONACHOL Odyssey Therapeutics

    INJECTION FDA: approved

  17. bevacizumab

    ABEVMY Amgen

    INTRAVENOUS FDA: approved · EMA: approved · TGA: approved · PMDA: approved · NMPA: clinical trials

    L01FG01

  18. bevacizumab-maly

    ALYMSYS Amneal Pharma Europe Ltd

    INJECTION FDA: approved

  19. bexarotene

    TARGRETIN Amneal Pharma Europe Ltd

    TOPICAL FDA: approved · EMA: approved

    L01XF03

  20. bicalutamide

    APO-BICALUTAMIDE Alphapharm Pty Ltd

    ORAL FDA: approved · TGA: approved

  21. bimatoprost

    BIMATOPROST SANDOZ Alphapharm Pty Ltd

    OPHTHALMIC FDA: approved · EMA: approved · TGA: approved

    S01EE03

  22. binimetinib

    MEKTOVI Pierre Fabre Australia Pty Ltd

    ORAL FDA: approved · EMA: approved · TGA: approved · PMDA: approved

    L01EE03

  23. bisoprolol fumarate

    BISOPROLOL FUMARATE Teva Pharma GmbH

    ORAL FDA: approved

  24. bivalirudin

    BIVALIRUDIN ARX Lacuna Pharma Pty Ltd

    INJECTION FDA: approved · EMA: withdrawn · TGA: approved

    B01AE06

Frequently asked questions

How many fda approved drugs are listed?

2,719 drug profiles match this regulatory segment in our published index.

Where does approval data come from?

Profiles combine FDA Drugs@FDA, EMA EPAR references, and regional authority feeds. See our data sources page for attribution.

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