Musculoskeletal Disorders

• FDA approval · 2025-07-30
  FDA Approved: ATMEKSI — Original Application (Rosemont Pharmaceuticals LLC)

  FDA approved ATMEKSI (methocarbamol) from Rosemont Pharmaceuticals LLC via Original Application, providing a methocarbamol product for relie…

• FDA approval · 2025-05-23
  FDA Approved: METAXALONE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Metaxalone from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2024-12-17
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith Laboratories’ supplemental application for cyclobenzaprine hydrochloride, enabling changes to the product labe…

• FDA approval · 2024-08-14
  FDA Approved: ORPHENADRINE CITRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Orphenadrine citrate, enabling a new generic version of the muscle relaxant…

• FDA approval · 2024-01-22
  FDA Approved: CHLORZOXAZONE — Original Application (Cintex Services, LLC)

  FDA approved the original application for CHLORZOXAZONE, a generic muscle relaxant, from Cintex Services, LLC.

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• FDA approval · 2023-08-09
  FDA Approved: CHLORZOXAZONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma's original ANDA for chlorzoxazone (generic) as a muscle relaxant to relieve muscle spasm associated with acute mu…

• FDA approval · 2023-06-12
  FDA Approved: METHOCARBAMOL — Original Application (FH2 PHARMA LLC)

  FDA approved FH2 PHARMA LLC's original application for methocarbamol (generic) under the ANDA pathway.

• FDA approval · 2022-07-15
  FDA Approved: METHOCARBAMOL — Supplemental Application (Trifluent Pharma LLC)

  The FDA approved a supplemental application for Methocarbamol filed by Trifluent Pharma LLC. This action updates the regulatory status of Me…

• FDA approval · 2022-04-05
  FDA Approved: CHLORZOXAZONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for chlorzoxazone (a generic muscle relaxant) from Rising Pharma Holdings, Inc.

• 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 · 2020-08-04
  FDA Approved: METHOCARBAMOL — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for methocarbamol filed by Sagent Pharmaceuticals for the generic product. The action authorizes an …

• FDA approval · 2020-07-14
  FDA Approved: METHOCARBAMOL — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved a supplemental application for methocarbamol tablets from Granules Pharmaceuticals Inc.

• FDA approval · 2020-07-02
  FDA Approved: METHOCARBAMOL — Supplemental Application (GENTEX PHARMA, LLC)

  FDA approved a supplemental application for methocarbamol from Gentex Pharma, LLC. This action grants regulatory approval under the suppleme…

• FDA approval · 2020-05-01
  FDA Approved: CARISOPRODOL — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Carisoprodol submitted by Westminster Pharmaceuticals, LLC.

• FDA approval · 2019-09-23
  FDA Approved: METAXALONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Metaxalone (METAXALONE) from Amneal Pharmaceuticals LLC under ANDA203399.

• FDA approval · 2019-04-04
  FDA Approved: SOMA — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Soma (carisoprodol) submitted by Viatris Specialty LLC.

• FDA approval · 2019-04-02
  FDA Approved: CARISOPRODOL — Supplemental Application (Vensun Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for carisoprodol from Vensun Pharmaceuticals, Inc., marking an approved change to the product's …

• FDA approval · 2018-11-13
  FDA Approved: CARISOPRODOL — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for carisoprodol submitted by Wilshire Pharmaceuticals, Inc.

• FDA approval · 2018-10-26
  FDA Approved: METHOCARBAMOL — Original Application (Sagent Pharmaceuticals)

  FDA approved an original application for a generic methocarbamol product from Sagent Pharmaceuticals.

• FDA approval · 2018-04-17
  FDA Approved: METHOCARBAMOL — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA, LLC's original application for a generic methocarbamol product (ANDA 209331), establishing a generic option…

• FDA approval · 2017-07-31
  FDA Approved: METHOCARBAMOL — Original Application (Somerset Therapeutics, LLC)

  FDA approved Somerset Therapeutics' original ANDA for methocarbamol (generic) for relief of discomfort associated with acute musculoskeletal…

• FDA approval · 2017-06-15
  FDA Approved: METAXALONE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s generic Metaxalone under an Original Application for relief of muscle spasm associated with musculoskele…

• FDA approval · 2016-06-24
  FDA Approved: CHLORZOXAZONE — Original Application (Solubiomix)

  FDA approves the Original Application for chlorzoxazone, a generic muscle relaxant manufactured by Solubiomix, for short-term relief of musc…

• FDA approval · 2014-08-12
  FDA Approved: ROBAXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Robaxin (methocarbamol) submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2014-01-27
  FDA Approved: CARISOPRODOL — Original Application (Vensun Pharmaceuticals, Inc.)

  The FDA approved an original ANDA for a generic carisoprodol manufactured by Vensun Pharmaceuticals, completing the generic entry for this m…