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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 20 of 114

  1. isradipine

    ISRADIPINE ELITE PHARMACEUTICALS INC /NV/

    ORAL FDA: approved

  2. itraconazole

    ITRACAP Alphapharm Pty Ltd

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

  3. ivacaftor

    KALYDECO Vertex Pharmaceuticals (Australia) Pty.

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

    R07AX32

  4. ivermectin

    STROMECTOL Merck KGaA, Darmstadt, Germany

    TOPICAL FDA: approved · TGA: approved

  5. ivosidenib

    TIBSOVO Servier Laboratories (Aust.) Pty.

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

    L01XM02

  6. ixazomib citrate

    NINLARO Takeda

    ORAL FDA: approved · PMDA: approved

  7. ketoconazole

    KETOCONAZOLE AID-SCFM S.A.

    TOPICAL FDA: approved · EMA: approved

    J02AB02

  8. ketoprofen

    DIRACTIN Teva Pharma GmbH

    ORAL FDA: approved · EMA: application withdrawn

  9. ketorolac tromethamine

    ACULAR LS Amphastar France Pharmaceuticals

    NASAL FDA: approved

  10. ketotifen fumarate

    KETOTIFEN FUMARATE Essential Pharma Limited

    OPHTHALMIC FDA: approved

  11. labetalol hydrochloride

    TRANDATE Amneal Pharma Europe Ltd

    INJECTION FDA: approved

  12. lacosamide

    LACOMED Alphapharm Pty Ltd

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

    N03AX18

  13. lactulose

    ACILAC Teva Pharma GmbH

    ORAL, RECTAL FDA: approved · NMPA: clinical trials

  14. lamivudine

    3TC ViiV Healthcare Pty Ltd

    ORAL FDA: approved · EMA: approved · TGA: approved · NMPA: clinical trials

    J05AF05

  15. lamotrigine

    APX-LAMOTRIGINE Alphapharm Pty Ltd

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

  16. lansoprazole

    APO-LANSOPRAZOLE Pfizer Australia Pty Ltd

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

  17. lanthanum carbonate

    LANTHANUM CARBONATE Takeda

    ORAL FDA: approved

  18. lapatinib ditosylate

    LAPATINIB DITOSYLATE Teva Pharma GmbH

    ORAL FDA: approved

  19. leflunomide

    APO-LEFLUNOMIDE Alphapharm Pty Ltd

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

    L04AK01

  20. lenalidomide

    LENALIDE Bristol-Myers Squibb Australia Pty Ltd

    ORAL FDA: approved · EMA: approved · TGA: approved · NMPA: clinical trials

    L04AX07

  21. lesinurad

    ZURAMPIC IRONWOOD PHARMACEUTICALS INC

    ORAL FDA: approved · EMA: withdrawn

    M04AB05

  22. letrozole

    ARX-LETROZOLE Novartis Pharmaceuticals

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

  23. leucovorin calcium

    LEUCOVORIN CALCIUM Regeneron Ireland Designated Activity Company (DAC)

    INJECTION FDA: approved

  24. leuprolide acetate

    LUPANETA PACK Amneal Pharma Europe Ltd

    IMPLANTATION FDA: approved

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.

Drug approvals, clinical trials, M&A, event intelligence, and company updates — weekly.

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