Muscle Spasm

• 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 · 2020-07-21
  FDA Approved: CHLORZOXAZONE — Original Application (Mayne Pharma Commercial LLC)

  FDA approved Mayne Pharma's original application for chlorzoxazone, a generic skeletal muscle relaxant indicated for relief of muscle spasm …

• 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 · 2020-07-06
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved cyclobenzaprine hydrochloride as a generic drug under an original ANDA from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2020-04-24
  FDA Approved: CARISOPRODOL — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for carisoprodol from Ingenus Pharmaceuticals, LLC, granting approval of a generic version of the mu…

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• 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 · 2019-09-12
  FDA Approved: CHLORZOXAZONE — Original Application (Novitium Pharma LLC)

  FDA approved the original application for chlorzoxazone, a muscle relaxant, with Novitium Pharma LLC as the manufacturer.

• FDA approval · 2019-02-21
  FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)

  The FDA approved a supplemental application for diazepam from Hospira, Inc., indicating updated labeling and continued availability under th…

• FDA approval · 2018-11-13
  FDA Approved: CARISOPRODOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Carisoprodol from Rising Pharma Holdings, Inc., completing a supplemental approval for this …

• 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.

• CLINICAL_TRIALS trial_result · 2018-06-11
  Clinical Trial Update: Low Intensity Ultrasound Therapy for Upper Back Pain Relief [NA]

  A completed clinical trial evaluating low intensity ultrasound therapy for upper back pain due to muscle spasm; results posted in 2018.

• FDA approval · 2018-05-07
  FDA Approved: METHOCARBAMOL — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals Inc.'s original application for methocarbamol tablets, a skeletal muscle relaxant used for short-term …

• 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 · 2018-03-13
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for cyclobenzaprine hydrochloride (Upsher-Smith Laboratories, LLC).

• FDA approval · 2017-08-31
  FDA Approved: METAXALONE — Original Application (BluePoint Laboratories)

  FDA approved the original application for metaxalone as a generic (ANDA 207466) manufactured by BluePoint Laboratories for relief of muscle …

• 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 · 2017-07-21
  FDA Approved: METHOCARBAMOL — Original Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved the original application for a generic methocarbamol product from UNICHEM Pharmaceuticals (USA), Inc.

• FDA approval · 2017-07-18
  FDA Approved: METHOCARBAMOL — Original Application (Sagent Pharmaceuticals)

  The FDA approved Sagent Pharmaceuticals’ original application for methocarbamol (generic). It covers its use as a muscle-relaxant for short-…

• 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 · 2017-05-31
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (Advagen Pharma Limited)

  FDA approved Cyclobenzaprine hydrochloride as an original application generic product manufactured by Advagen Pharma Limited.

• 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 · 2017-01-31
  FDA Approved: CARISOPRODOL — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Carisoprodol from Wilshire Pharmaceuticals, Inc., granting approval to market a generic vers…

• FDA approval · 2017-01-19
  FDA Approved: METHOCARBAMOL — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved the original application for a generic methocarbamol product by Slate Run Pharmaceuticals, LLC.

• FDA approval · 2016-11-22
  FDA Approved: METAXALONE — Original Application (Lannett Company, Inc.)

  FDA approved the original ANDA for metaxalone (METAXALONE) filed by Lannett Company, Inc., establishing a generic product.