Osteoarthritis

• FDA approval · 2021-04-28
  FDA Approved: RELAFEN DS — Supplemental Application (Carwin Pharmaceutical Associates, LLC)

  FDA approved a supplemental application for Relafen DS (nabumetone) submitted by Carwin Pharmaceutical Associates, LLC. Nabumetone is used t…

• FDA approval · 2021-04-28
  FDA Approved: NABUMETONE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Nabumetone submitted by Actavis Pharma, Inc., relating to Nabumetone's approval status.

• FDA approval · 2021-04-28
  FDA Approved: IBUPROFEN — Supplemental Application (Major Pharmaceuticals)

  The FDA approved Major Pharmaceuticals' ibuprofen supplemental application, finalizing regulatory changes for this product under an ANDA pro…

• FDA approval · 2021-04-28
  FDA Approved: NABUMETONE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Nabumetone from Exelan Pharmaceuticals Inc. to modify an aspect of the approved product. This ac…

• FDA approval · 2021-04-28
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Tolmetin Sodium from Atland Pharmaceuticals, LLC, updating an existing approval.

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• FDA approval · 2021-04-26
  FDA Approved: DICLOFENAC POTASSIUM — Supplemental Application (Trifluent Pharma LLC)

  FDA approved a supplemental application for Diclofenac potassium from Trifluent Pharma LLC as a generic product.

• FDA approval · 2021-04-26
  FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Indomethacin submitted by XLCare Pharmaceuticals Inc. under ANDA 091240.

• FDA approval · 2021-04-26
  FDA Approved: ETODOLAC — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Etodolac from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2021-03-31
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Diclofenac Sodium from Actavis Pharma, Inc. under ANDA074514. The approval covers an updated for…

• FDA approval · 2021-03-26
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved Oceanside Pharmaceuticals' supplemental application for diclofenac sodium (a generic NSAID).

• FDA approval · 2021-03-04
  FDA Approved: TAPENTADOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Tapentadol hydrochloride by Hikma Pharmaceuticals USA Inc., resulting in an updated labeling…

• FDA approval · 2020-12-16
  FDA Approved: ETODOLAC — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved the original ANDA for etodolac from Unichem Pharmaceuticals (USA), Inc., a generic NSAID. It is indicated for relief of sig…

• FDA approval · 2020-12-12
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., resulting in changes to the product labeling. This act…

• FDA approval · 2020-12-03
  FDA Approved: CELECOXIB — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original ANDA for Celecoxib from ScieGen Pharmaceuticals, a generic version of the COX-2 inhibitor used for pain relief. It…

• 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 · 2020-10-01
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

  FDA approves a supplemental application for Cymbalta (duloxetine hydrochloride) submitted by Eli Lilly and Company.

• FDA approval · 2020-09-24
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for the diclofenac sodium and misoprostol product from Mylan Pharmaceuticals, updating its label…

• FDA approval · 2020-08-11
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for diclofenac sodium topical gel, 1%, from BluePoint Laboratories. The action pertains to a gen…

• 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 …

• FDA approval · 2020-06-01
  FDA Approved: MELOXICAM — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' MELOXICAM as an original-application generic meloxicam; the drug is indicated for relief of pain and inf…

• FDA approval · 2020-05-08
  FDA Approved: IBUPROFEN — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's ibuprofen generic under Original Application (ANDA213794). The product is a generic version of ibupr…

• FDA approval · 2020-04-01
  FDA Approved: ARTHRITIS PAIN RELIEVER — Supplemental Application (Publix Super Markets Inc)

  FDA approved a supplemental application for Publix Super Markets Inc's arthritis pain reliever containing diclofenac sodium under an ANDA.

• 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 · 2020-03-06
  FDA Approved: CELECOXIB — Original Application (Chartwell RX, LLC)

  FDA approved the original generic application for celecoxib (Celecoxib) by Chartwell RX, LLC.

• FDA approval · 2020-02-25
  FDA Approved: CELECOXIB — Original Application (EPIC PHARMA, LLC)

  FDA approved the Original Application (ANDA) for a generic Celecoxib product from Epic Pharma, LLC, enabling its marketing as a COX-2 inhibi…