Musculoskeletal Conditions

• FDA approval · 2025-08-15
  FDA Approved: TONMYA — Original Application (Tonix Medicines, Inc.)

  FDA approved TONMYA (cyclobenzaprine hydrochloride) from Tonix Medicines, Inc. as the original NDA approval for treating muscle spasm associ…

• FDA approval · 2018-10-26
  FDA Approved: CARISOPRODOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Carisoprodol by Rising Pharma Holdings, Inc., resulting in updated regulatory clearance for the …

• FDA approval · 2017-05-11
  FDA Approved: CARISOPRODOL — Original Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals, LLC's original application for Carisoprodol (generic) to treat short-term relief of discomfort…

• FDA approval · 2016-11-08
  FDA Approved: CARISOPRODOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for carisoprodol by Rising Pharma Holdings, Inc., enabling the generic product to be marketed.

• FDA approval · 2013-04-30
  FDA Approved: CARISOPRODOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for carisoprodol by Rising Pharma Holdings, Inc., indicating an approved modification to the existin…

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• FDA approval · 2013-04-11
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (SA3, LLC)

  FDA approved a supplemental application for cyclobenzaprine hydrochloride (SA3, LLC), indicating approval of a supplemental submission for a…

• FDA approval · 2013-04-11
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (KVK-TECH, Inc.)

  FDA approved a supplemental application for cyclobenzaprine hydrochloride from KVK-Tech, Inc., allowing the generic product to proceed under…

• FDA approval · 2011-11-16
  FDA Approved: CARISOPRODOL — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved a supplemental application to authorize a generic Carisoprodol product from Ingenus Pharmaceuticals, LLC.