Osteoarthritis

• FDA approval · 2020-02-19
  FDA Approved: DICLOFENAC SODIUM MISOPROSTOL — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved the original application for diclofenac sodium and misoprostol, a generic diclofenac/misoprostol combination product manufactur…

• FDA approval · 2020-02-18
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited for Naproxen and Esomeprazole Magnesium under an Original Application (ANDA) for a generic Nap…

• FDA approval · 2020-02-14
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  FDA approves a supplemental application for Voltaren Arthritis Pain (diclofenac sodium) by Haleon US Holdings LLC to expand the labeling for…

• FDA approval · 2020-01-27
  FDA Approved: DICLOFENAC SODIUM — Original Application (BluePoint Laboratories)

  FDA approved diclofenac sodium topical gel, 1%, under an Original Application (ANDA) by BluePoint Laboratories for relief of osteoarthritis …

• FDA approval · 2019-12-23
  FDA Approved: PIROXICAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for Piroxicam (PIROXICAM). This is a supplemental approval affecting the PIROXICAM product.

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• FDA approval · 2019-12-03
  FDA Approved: DICLOFENAC POTASSIUM — Original Application (Lifsa Drugs LLC)

  FDA approved the original application for diclofenac potassium as a generic NSAID for relief of pain and inflammation associated with variou…

• FDA approval · 2019-12-02
  FDA Approved: MELOXICAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for meloxicam by Aurobindo Pharma Limited. The approval covers changes approved under this supplemen…

• FDA approval · 2019-11-27
  FDA Approved: CELECOXIB — Original Application (NIVAGEN PHARMACEUTICALS, INC.)

  The FDA approved NIVAGEN Pharmaceuticals, Inc.'s original application for a generic celecoxib product.

• FDA approval · 2019-11-22
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (CVS)

  FDA approved a supplemental application for Naproxen Sodium from CVS under ANDA 091353, resulting in updated approval for the product.

• 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 · 2019-11-14
  FDA Approved: CELECOXIB — Original Application (Modavar Pharmaceuticals LLC)

  The FDA approved Modavar Pharmaceuticals LLC's original application for a generic version of celecoxib (Celecoxib).

• FDA approval · 2019-10-26
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., resulting in an approved modification to the product’s lab…

• FDA approval · 2019-10-22
  FDA Approved: MELOXICAM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for Meloxicam from Unichem Pharmaceuticals (USA), Inc. under ANDA 077927.

• FDA approval · 2019-10-17
  FDA Approved: PIROXICAM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for PIROXICAM from Unichem Pharmaceuticals (USA), Inc. (a generic piroxicam product).

• FDA approval · 2019-10-09
  FDA Approved: CELECOXIB — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Celecoxib submitted by Actavis Pharma, Inc.

• FDA approval · 2019-10-07
  FDA Approved: PIROXICAM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for piroxicam by Micro Labs Limited, adding or updating a generic piroxicam product.

• FDA approval · 2019-09-11
  FDA Approved: OXAPROZIN — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Oxaprozin from Dr. Reddy's Laboratories Limited, updating the existing approval for this generic…

• FDA approval · 2019-08-30
  FDA Approved: RELAFEN DS — Original Application (Carwin Pharmaceutical Associates, LLC)

  FDA approval of RELAFEN DS (nabumetone) through an original generic application by Carwin Pharmaceutical Associates, expanding access to thi…

• FDA approval · 2019-08-16
  FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Yaopharma Co., Ltd.)

  FDA approved the original application for duloxetine hydrochloride from Yaopharma Co., Ltd., granting approval for the generic product to be…

• FDA approval · 2019-08-07
  FDA Approved: CELECOXIB — Original Application (AiPing Pharmaceutical, Inc.)

  The FDA approved AiPing Pharmaceutical, Inc.'s original ANDA for celecoxib, establishing a generic version of the COX-2 inhibitor. The appro…

• FDA approval · 2019-07-25
  FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for celecoxib from Apotex Corp., granting approval for a generic version of the product.

• FDA approval · 2019-07-25
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's supplemental application for Celecoxib (generic Celecoxib), confirming the generic's approval. Celec…

• FDA approval · 2019-07-22
  FDA Approved: IBUPROFEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal Pharmaceuticals of New York LLC's supplemental application for a generic ibuprofen product. The approval confirms the ge…

• FDA approval · 2019-07-22
  FDA Approved: IBUPROFEN — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for ibuprofen from Chartwell RX, LLC under ANDA 202413, authorizing the specified changes to thi…

• FDA approval · 2019-07-22
  FDA Approved: IBUPROFEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for ibuprofen by Amneal Pharmaceuticals of New York LLC.