Dysmenorrhea

• FDA approval · 2025-12-17
  FDA Approved: PERIOD PILLS BY BIIKAY — Supplemental Application (Kai Squared)

  The FDA approved a supplemental application for Period Pills by BIIKAY, a combination product of acetaminophen and ibuprofen manufactured by…

• FDA approval · 2025-12-12
  FDA Approved: MEDROXYPROGESTERONE ACETATE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Medroxyprogesterone acetate from Prasco Laboratories, resulting in labeling changes associat…

• 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 · 2025-07-29
  FDA Approved: VYSCOXA — Original Application (Carwin Pharmaceutical Associates, LLC)

  FDA approved VYSCOXA, a brand name for celecoxib, under Carwin Pharmaceutical Associates, LLC's original application. This confirms marketin…

• FDA approval · 2025-06-17
  FDA Approved: MEFENAMIC ACID — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for mefenamic acid from Micro Labs Limited, approving continued marketing of the generic product.

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• FDA approval · 2025-02-26
  FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for Celecoxib (celecoxib), authorizing a generic version under the ANDA pathway. The ac…

• 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 · 2025-02-15
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen (ANDA074190) from Hikma Pharmaceuticals USA Inc., resulting in an updated approval of t…

• FDA approval · 2024-12-19
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA supplemental approval for Aurobindo Pharma Limited's generic celecoxib.

• FDA approval · 2024-11-21
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for a generic diclofenac sodium product from NorthStar Rx LLC.

• FDA approval · 2024-11-21
  FDA Approved: CELEBREX — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Celebrex (celecoxib) filed by Viatris Specialty LLC. The approval covers changes requested i…

• FDA approval · 2024-11-21
  FDA Approved: IBUPROFEN — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for ibuprofen from Actavis Pharma, Inc.

• FDA approval · 2024-09-27
  FDA Approved: CELECOXIB — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Celecoxib from Actavis Pharma, Inc.

• FDA approval · 2024-06-14
  FDA Approved: DICLOFENAC POTASSIUM — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a generic diclofenac potassium tablet from Taro Pharmaceuticals U.S.A., Inc. under an original ANDA for relief of pain in sever…

• FDA approval · 2024-03-27
  FDA Approved: PERIOD PILLS BY BIIKAY — Supplemental Application (Kai Squared)

  FDA approved a supplemental application for PERIOD PILLS BY BIIKAY, a combination of acetaminophen and ibuprofen, intended for menstrual per…

• FDA approval · 2023-07-13
  FDA Approved: PERIOD PILLS BY BIIKAY — Original Application (Kai Squared)

  FDA approved PERIOD PILLS BY BIIKAY, a combination product of acetaminophen and ibuprofen, under Kai Squared's Original Application for reli…

• FDA approval · 2023-05-05
  FDA Approved: IBUPROFEN — Supplemental Application (Winco Foods, LLC)

  The FDA approved a supplemental application for a generic ibuprofen product developed by Winco Foods, LLC.

• FDA approval · 2022-11-15
  FDA Approved: CAREONE IBUPROFEN — Supplemental Application (American Sales Company)

  The FDA approved a supplemental application for CAREONE IBUPROFEN (ibuprofen) filed by American Sales Company under ANDA077349.

• FDA approval · 2022-10-06
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s Naproxen and Esomeprazole Magnesium as an Original Application (ANDA213699), providing a generic versi…

• 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 · 2022-06-07
  FDA Approved: NAPROXEN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber's naproxen generic original application for Naproxen. This generic NSAID is approved for relief of pain and inflammation…

• FDA approval · 2022-05-06
  FDA Approved: DICLOFENAC SODIUM — Original Application (Apotex Corp.)

  FDA approved Apotex Corp's original application for diclofenac sodium tablets, a generic NSAID. This approval enables Apotex to market a gen…

• FDA approval · 2022-03-11
  FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)

  FDA approved a supplemental application for naproxen sodium granules from Granules India Ltd, resulting in an approved supplemental request …

• FDA approval · 2022-03-09
  FDA Approved: CELECOXIB — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Celecoxib from Micro Labs Limited under an ANDA.

• FDA approval · 2022-01-11
  FDA Approved: CELECOXIB — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  The FDA approved a supplemental application for Celecoxib submitted by NIVAGEN Pharmaceuticals, Inc., for a generic Celecoxib product.