Osteoarthritis

• FDA label_change · 2024-11-21
  FDA Approved: ETODOLAC — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Etodolac from ANI Pharmaceuticals, updating the labeling for this generic product.

• FDA label_change · 2024-11-21
  FDA Approved: ETODOLAC — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Etodolac by Zydus Pharmaceuticals USA Inc., resulting in labeling updates for this NSAID.

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

  FDA approved a supplemental labeling change for sulindac from Actavis Pharma, updating the product labeling under the ANDA. This reflects ad…

• FDA label_change · 2024-11-21
  FDA Approved: DAYPRO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental labeling application for DAYPRO (oxaprozin) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA label_change · 2023-05-10
  FDA Approved: METHYLPREDNISOLONE ACETATE — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for methylprednisolone acetate by Sandoz Inc.

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• FDA label_change · 2018-02-21
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application to Voltaren Arthritis Pain to update the product’s labeling for arthritis pain relief with diclo…

• FDA label_change · 2016-09-13
  FDA Approved: CELECOXIB — Supplemental Application (Cipla USA Inc.)

  FDA Approved: CELECOXIB — Supplemental Application (Cipla USA Inc.) indicating a labeling modification related to celecoxib.

• FDA label_change · 2016-05-09
  FDA Approved: DIFLUNISAL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for DIFLUNISAL (diflunisal) from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., indi…

• FDA label_change · 2015-04-01
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for DICLOFENAC SODIUM AND MISOPROSTOL from Mylan Pharmaceuticals, updating the labeling for this dic…

• FDA label_change · 2014-11-25
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Voltaren Arthritis Pain (diclofenac sodium) filed by Haleon US Holdings LLC. The approval update…

• FDA label_change · 2010-05-06
  FDA Approved: TYLENOL 8 HR ARTHRITIS PAIN — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental labeling submission for TYLENOL 8 HR ARTHRITIS PAIN (acetaminophen) filed by Kenvue Brands LLC to update the pro…