Osteoarthritis

• FDA approval · 2024-11-21
  FDA Approved: MELOXICAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for MELOXICAM (meloxicam) under ANDA077944.

• 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: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for Indomethacin from Amneal Pharmaceuticals LLC (ANDA 091549), authorizing a supplemental change to…

• FDA approval · 2024-11-21
  FDA Approved: ETODOLAC — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for Etodolac submitted by Taro Pharmaceuticals U.S.A., Inc.

• FDA approval · 2024-11-21
  FDA Approved: ETODOLAC — Supplemental Application (Apotex Corp.)

  FDA approves a supplemental ANDA for etodolac from Apotex Corp.

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• 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: DICLOFENAC SODIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Diclofenac Sodium Topical from Alembic Pharmaceuticals Limited.

• FDA approval · 2024-11-21
  FDA Approved: MELOXICAM — Supplemental Application (AiPing Pharmaceutical, Inc)

  FDA approved a supplemental application for meloxicam from AiPing Pharmaceutical, Inc. The approval pertained to updating the labeling under…

• FDA approval · 2024-11-21
  FDA Approved: NABUMETONE — Supplemental Application (Chartwell RX, LLC)

  FDA has approved a supplemental application for NABUMETONE submitted by Chartwell RX, LLC. The action updates an existing approved ANDA for …

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

  The FDA approved a supplemental application for Nabumetone submitted by Actavis Pharma, Inc., representing a regulatory change to the existi…

• FDA approval · 2024-11-21
  FDA Approved: MELOXICAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for meloxicam, confirming regulatory clearance for the product.

• FDA approval · 2024-11-21
  FDA Approved: MELOXICAM — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for MELOXICAM from Cipla USA Inc., authorizing changes to an existing meloxicam product under an…

• 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 · 2024-08-16
  FDA Approved: DIFLUNISAL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental abbreviated new drug application for DIFLUNISAL (diflunisal) from Heritage Pharmaceuticals d/b/a Avet Pharma…

• FDA approval · 2024-08-07
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved Haleon's supplemental application for Voltaren Arthritis Pain (diclofenac sodium), updating the product labeling to support…

• FDA approval · 2024-08-01
  FDA Approved: ETODOLAC — Original Application (Ipca Laboratories Limited)

  FDA approved the etodolac generic product from Ipca Laboratories Limited under an original application (ANDA).

• FDA approval · 2024-07-29
  FDA Approved: BROMFENAC — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's bromfenac as a generic under Original Application ANDA210962. Bromfenac is approved as an N…

• FDA approval · 2024-07-26
  FDA Approved: FENOPRON TM — Supplemental Application (Galt Pharmaceuticals, LLC)

  FDA approves a supplemental application for Fenoprofen calcium (FENOPRON TM) by Galt Pharmaceuticals, LLC, to update the product labeling.

• 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 · 2024-05-01
  FDA Approved: ETODOLAC — Original Application (Ipca Laboratories Limited)

  FDA approved Etodolac from Ipca Laboratories Limited as a generic product (Original Application under ANDA 204729). It is indicated for reli…

• FDA approval · 2024-03-29
  FDA Approved: DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for the generic Diclofenac Sodium/Misoprostol product from Micro Labs Limited, authorizing its marke…

• FDA approval · 2024-03-21
  FDA Approved: DICLOFENAC SODIUM MISOPROSTOL — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Diclofenac Sodium with Misoprostol (Nivagen Pharmaceuticals, Inc.). The labeling supports use fo…

• FDA approval · 2024-03-15
  FDA Approved: ETODOLAC — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Etodolac from Amneal Pharmaceuticals NY LLC. The action adds to the existing approval for this N…

• FDA approval · 2023-12-28
  FDA Approved: MELOXICAM — Supplemental Application (AiPing Pharmaceutical, Inc)

  FDA approved AiPing Pharmaceutical, Inc.'s supplemental application for MELOXICAM (meloxicam).