Musculoskeletal Disorders

• FDA approval · 2013-07-26
  FDA Approved: CARISOPRODOL — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for carisoprodol filed by Chartwell RX, LLC. This action confirms regulatory approval for the muscle…

• FDA approval · 2011-02-28
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (KVK-TECH, Inc.)

  FDA approved cyclobenzaprine hydrochloride from KVK-Tech under an original ANDA, enabling marketing of this generic muscle relaxant for acut…

• FDA approval · 2009-11-06
  FDA Approved: SOMA — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2009-11-06
  FDA Approved: METHOCARBAMOL — Original Application (XLCare Pharmaceuticals Inc.)

  FDA approved methocarbamol as a generic product via an Original Application submitted by XLCare Pharmaceuticals Inc. The approval provides a…

• FDA approval · 2009-08-06
  FDA Approved: CARISOPRODOL — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma's original ANDA for carisoprodol, enabling a generic version of the muscle relaxant to be marketed. This repr…

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• FDA approval · 2008-08-07
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approved a supplemental application for cyclobenzaprine hydrochloride (Solco Healthcare U.S., LLC) under an ANDA.

• FDA approval · 2008-05-12
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (SA3, LLC)

  FDA approved SA3, LLC's original generic application for cyclobenzaprine hydrochloride (cyclobenzaprine HCl), a muscle relaxant used for sho…

• FDA approval · 2008-04-18
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals Inc.'s generic cyclobenzaprine hydrochloride under an Original Application, making a generic option…

• FDA approval · 2007-04-16
  FDA Approved: ORPHENADRINE CITRATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Orphenadrine citrate from Actavis Pharma, Inc., resulting in regulatory action on the generic pr…

• FDA approval · 2007-02-01
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Cyclobenzaprine hydrochloride from Amneal Pharmaceuticals of New York LLC under an original application. The drug is intended f…