Bursitis

• FDA approval · 2025-10-03
  FDA Approved: NAPROXEN — Original Application (Aurobindo Pharma Limited)

  FDA approved Naproxen from Aurobindo Pharma Limited as an original generic application (ANDA 216504). Naproxen is a nonsteroidal anti-inflam…

• FDA approval · 2025-02-24
  FDA Approved: INDOMETHACIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's original application for Indomethacin, authorizing a generic version of the NSAID with the same…

• FDA approval · 2022-09-06
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (CVS)

  The FDA approved a supplemental application for naproxen sodium sponsored by CVS.

• FDA approval · 2020-10-28
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Aleve GelCaps (naproxen sodium) as a new gelcap dosage form for naproxen sodium, expanding th…

• FDA approval · 2020-07-28
  FDA Approved: NAPROXEN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Naproxen from Glenmark Pharmaceuticals to update the labeling for the generic product under the …

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• FDA approval · 2020-03-19
  FDA Approved: NAPROXEN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's supplemental application for naproxen (generic) under ANDA075390. This action constitutes a suppleme…

• FDA approval · 2019-11-15
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for a generic Naproxen product from Hikma Pharmaceuticals USA Inc. This action expands access to…

• FDA approval · 2016-05-09
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

  FDA approved a supplemental application for Naproxen submitted by Zameer Pharmaceuticals LLC.

• FDA approval · 2014-11-02
  FDA Approved: NAPROXEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Naproxen by Amneal Pharmaceuticals of New York LLC (generic Naproxen).

• FDA approval · 2014-10-16
  FDA Approved: INDOCIN — Supplemental Application (Zyla Life Sciences US LLC)

  FDA approved a supplemental application for Indocin (indomethacin) submitted by Zyla Life Sciences US LLC.

• FDA approval · 2011-09-19
  FDA Approved: NAPROXEN — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s Naproxen under Original Application, making a generic naproxen product available. It is used to relieve pain a…

• FDA approval · 2010-03-17
  FDA Approved: INDOMETHACIN — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved an original NDA for indomethacin from Fresenius Kabi USA, LLC. The approval covers indications for inflammatory and musculo…

• FDA approval · 2007-09-25
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen from Hikma Pharmaceuticals USA Inc., indicating an approved change or addition to the N…

• FDA approval · 2007-03-28
  FDA Approved: NAPROXEN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's naproxen generic under an original ANDA, enabling market access for generic naproxen products.