Osteoarthritis

• 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 · 2022-02-08
  FDA Approved: PIROXICAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Piroxicam submitted by Teva Pharmaceuticals USA, Inc.

• 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.

• FDA approval · 2022-01-07
  FDA Approved: MELOXICAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for meloxicam, authorizing the generic NSAID product. This marks regulatory…

• FDA approval · 2022-01-07
  FDA Approved: MELOXICAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for MELOXICAM (meloxicam) from Aurobindo Pharma Limited.

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• FDA approval · 2022-01-05
  FDA Approved: CELECOXIB — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic celecoxib product (Celecoxib) under ANDA 202240.

• FDA approval · 2021-11-03
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

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

• FDA approval · 2021-08-24
  FDA Approved: DICLOFENAC SODIUM 1.5% — Supplemental Application (SOLA Pharmaceuticals)

  The FDA approved a supplemental application for diclofenac sodium 1.5% topical from SOLA Pharmaceuticals.

• FDA approval · 2021-08-02
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Diclofenac Sodium and Misoprostol from Mylan Pharmaceuticals Inc.

• FDA approval · 2021-07-19
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

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

• FDA approval · 2021-07-15
  FDA Approved: DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL — Original Application (Micro Labs Limited)

  FDA approved the original application for a generic fixed-dose combination of diclofenac sodium and misoprostol from Micro Labs Limited.

• FDA approval · 2021-04-30
  FDA Approved: SULINDAC — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for sulindac from Sun Pharmaceutical Industries, Inc., authorizing changes to its labeling and/o…

• FDA approval · 2021-04-29
  FDA Approved: ETODOLAC — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Etodolac (Apotex Corp.), approving a generic version of etodolac under an ANDA.

• FDA approval · 2021-04-29
  FDA Approved: NABUMETONE — Supplemental Application (Chartwell RX, LLC)

  FDA approves a supplemental application for nabumetone submitted by Chartwell RX, LLC. Nabumetone is an NSAID used for pain relief in condit…

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

  The FDA approved a supplemental application for tolmetin sodium submitted by Atland Pharmaceuticals, LLC, resulting in updated labeling for …

• FDA approval · 2021-04-28
  FDA Approved: INDOCIN — Supplemental Application (Zyla Life Sciences US LLC)

  The FDA has approved a supplemental application for INDOCIN (indomethacin) by Zyla Life Sciences US LLC.

• FDA approval · 2021-04-28
  FDA Approved: NAPROXEN — Supplemental Application (Acella Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Naproxen filed by Acella Pharmaceuticals, LLC, updating the product's approval status.

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

  FDA approved a supplemental application for Nabumetone from ScieGen Pharmaceuticals Inc, resulting in updated labeling and potential new ind…

• FDA approval · 2021-04-28
  FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for Indomethacin, approving a generic Indomethacin product.

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

  FDA approved Lupin Pharmaceuticals' supplemental application for Nabumetone.

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

  FDA approved a supplemental application for Indomethacin from XLCare Pharmaceuticals Inc. This approval updates the drug's existing FDA appr…

• FDA approval · 2021-04-28
  FDA Approved: ETODOLAC — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Etodolac submitted by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2021-04-28
  FDA Approved: MECLOFENAMATE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for meclofenamate sodium from Mylan Pharmaceuticals Inc.

• FDA approval · 2021-04-28
  FDA Approved: ETODOLAC — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for etodolac from Amneal Pharmaceuticals NY LLC under ANDA 208834.

• FDA approval · 2021-04-28
  FDA Approved: ETODOLAC — Supplemental Application (Chartwell RX, LLC)

  The FDA has approved a supplemental application for etodolac submitted by Chartwell RX, LLC.