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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 32 of 114

  1. romidepsin

    ISTODAX Teva Pharma GmbH

    INTRAVENOUS FDA: approved · EMA: refused · PMDA: approved

    L01XX39

  2. ropeginterferon alfa-2b-njft

    BESREMI Essential Pharma Limited

    SUBCUTANEOUS FDA: approved

  3. ropinirole hydrochloride

    ROPINIROLE HYDROCHLORIDE ELITE PHARMACEUTICALS INC /NV/

    ORAL FDA: approved

  4. ropivacaine hydrochloride

    ROPIVACAINE HYDROCHLORIDE Amneal Pharma Europe Ltd

    INJECTION FDA: approved

  5. rosuvastatin calcium

    ROSUVASTATIN CALCIUM Amneal Pharma Europe Ltd

    ORAL FDA: approved

  6. salmeterol xinafoate

    AIREXAR SPIROMAX Teva Pharma GmbH

    INHALATION FDA: approved · EMA: withdrawn

    R03AK06

  7. sapropterin dihydrochloride

    SAPROPTERIN DIHYDROCHLORIDE BioMarin Pharmaceutical Australia Pty Ltd

    ORAL FDA: approved

  8. sarecycline hydrochloride

    SEYSARA Almirall, S.A.

    ORAL FDA: approved

  9. saxagliptin

    ONGLYZA AstraZeneca

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

    A10BD21

  10. saxagliptin hydrochloride

    SAXAGLIPTIN Amneal Pharma Europe Ltd

    ORAL FDA: approved

  11. scopolamine

    SCOPOLAMINE Amneal Pharma Europe Ltd

    TRANSDERMAL FDA: approved

  12. sebetralstat

    EKTERLY Kalvista Pharmaceuticals (Ireland) Limited

    ORAL FDA: approved · EMA: approved

    B06AC08

  13. secnidazole

    SOLOSEC Evofem Biosciences

    ORAL FDA: approved

  14. selenious acid

    SELENIOUS ACID Regeneron Ireland Designated Activity Company (DAC)

    SOLUTION FDA: approved

  15. selinexor

    XPOVIO Shanghai Antengene Corporation Limited

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

    L01XX66

  16. sepiapterin

    SEPHIENCE PTC THERAPEUTICS, INC.

    ORAL FDA: approved · EMA: approved

    A16AX28

  17. sertraline hydrochloride

    SERTRALINE HYDROCHLORIDE Amneal Pharma Europe Ltd

    ORAL FDA: approved

  18. setmelanotide acetate

    IMCIVREE Rhythm Pharmaceuticals Netherlands B.V.

    SUBCUTANEOUS FDA: approved

  19. sevelamer carbonate

    RENVELA Amneal Pharma Europe Ltd

    ORAL FDA: approved · EMA: approved

    V03AE02

  20. sildenafil citrate

    SILDENAFIL CITRATE Amneal Pharma Europe Ltd

    ORAL FDA: approved

  21. silodosin

    UROREC Lacuna Pharma Pty Ltd

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

    G04CA04

  22. simvastatin

    APO-SIMVASTATIN Alphapharm Pty Ltd

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

  23. sincalide

    SINCALIDE MAIA Biotechnology

    INTRAVENOUS FDA: approved

  24. sirolimus

    RAPAMUNE Pfizer Australia Pty Ltd

    TOPICAL FDA: approved · EMA: approved · TGA: approved · PMDA: approved

    L04AH01

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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