Musculoskeletal Pain

• FDA approval · 2013-04-18
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approves a supplemental application for Aleve GelCaps to expand labeling for naproxen sodium, broadening indications for pain relief.

• FDA approval · 2013-04-11
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approves a supplemental application for Cyclobenzaprine Hydrochloride (Solco Healthcare U.S., LLC), authorizing the generic product to b…

• 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 · 2013-04-11
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  The FDA approved a supplemental application for cyclobenzaprine hydrochloride (generic) from Jubilant Cadista Pharmaceuticals, approving an …

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

  FDA approved a supplemental application for cyclobenzaprine hydrochloride from Rising Pharma Holdings, Inc., confirming approval of a generi…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2013-04-11
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for cyclobenzaprine hydrochloride from Teva Pharmaceuticals USA, Inc., updating the existing approva…

• FDA approval · 2013-03-29
  FDA Approved: SALONPAS PAIN RELIEF — Supplemental Application (Hisamitsu Pharmaceutical Co., Inc.)

  The FDA approved a supplemental application for SALONPAS PAIN RELIEF (menthol and methyl salicylate) from Hisamitsu Pharmaceutical Co., Inc.…

• FDA approval · 2013-02-01
  FDA Approved: SOMA — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2013-01-31
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith's generic cyclobenzaprine hydrochloride for use as a muscle relaxant in acute musculoskeletal conditions under…

• FDA approval · 2012-09-28
  FDA Approved: METHOCARBAMOL — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for methocarbamol from Solco Healthcare LLC.

• 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.

• FDA approval · 2011-08-30
  FDA Approved: ORPHENADRINE CITRATE — Original Application (Sagent Pharmaceuticals)

  FDA approved Orphenadrine citrate under an Original Application for Sagent Pharmaceuticals.

• FDA approval · 2011-06-06
  FDA Approved: SALONPAS PAIN RELIEF — Supplemental Application (Hisamitsu Pharmaceutical Co., Inc.)

  FDA approved a supplemental application for SALONPAS PAIN RELIEF (menthol, methyl salicylate) from Hisamitsu Pharmaceutical Co., Inc.

• FDA approval · 2011-04-12
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Cymbalta (duloxetine hydrochloride) submitted by Eli Lilly and Company.

• FDA approval · 2010-03-30
  FDA Approved: ORPHENADRINE CITRATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for orphenadrine citrate submitted by Sandoz Inc.

• FDA approval · 2010-03-10
  FDA Approved: CARISOPRODOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Carisoprodol from Rising Pharma Holdings, Inc. The approval updates the regulatory status of thi…

• FDA approval · 2009-11-17
  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: 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 · 2009-09-03
  FDA Approved: FLECTOR — Supplemental Application (IBSA Pharma Inc.)

  FDA approved a supplemental application for FLECTOR (diclofenac epolamine) from IBSA Pharma Inc. The action pertains to modifications to the…

• FDA approval · 2009-01-29
  FDA Approved: CARISOPRODOL — Supplemental Application (Chartwell RX, LLC)

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

• FDA approval · 2009-01-06
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approved the supplemental application for cyclobenzaprine hydrochloride (Solco Healthcare U.S., LLC).

• FDA approval · 2008-10-22
  FDA Approved: CARISOPRODOL — Original Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved the original application for carisoprodol from Ingenus Pharmaceuticals, authorizing a generic version of this muscle relaxa…

• FDA approval · 2008-09-26
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved cyclobenzaprine hydrochloride from Rising Pharma Holdings, Inc. under an Original Application (ANDA) for relief of muscle spasm…

• FDA approval · 2008-08-25
  FDA Approved: SALONPAS PAIN RELIEF — Supplemental Application (Hisamitsu Pharmaceutical Co., Inc.)

  FDA approved a supplemental application for SALONPAS PAIN RELIEF (menthol, methyl salicylate) from Hisamitsu Pharmaceutical Co., Inc.