Musculoskeletal Pain

• FDA approval · 2017-03-23
  FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for duloxetine hydrochloride from Macleods Pharmaceuticals Limited, authorizing a generic version of d…

• 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 · 2017-01-06
  FDA Approved: DULOXETINE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved an Original Application (ANDA 208706) for duloxetine from Quallent Pharmaceuticals Health LLC, establishing a generic version o…

• FDA approval · 2017-01-04
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

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

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• 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.

• FDA approval · 2016-08-03
  FDA Approved: DULOXETINE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for a generic duloxetine product. Duloxetine is used to treat multiple conditi…

• 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 · 2016-05-25
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for cyclobenzaprine hydrochloride from Amneal Pharmaceuticals of New York LLC. This update confi…

• FDA approval · 2015-10-28
  FDA Approved: ALEVE PM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for ALEVE PM (diphenhydramine hydrochloride and naproxen sodium) to support its continued marketing …

• FDA approval · 2015-10-28
  FDA Approved: DULOXETINE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original ANDA for duloxetine, allowing a generic version to be marketed. The approval covers duloxetin…

• FDA approval · 2015-08-26
  FDA Approved: DULOXETINE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' original application for a generic duloxetine product (ANDA 203197), establishing a generic version of…

• FDA approval · 2014-09-26
  FDA Approved: DULOXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for duloxetine from Zydus Lifesciences Limited under an ANDA. The approval involves changes to the a…

• 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 · 2014-06-11
  FDA Approved: DULOXETINE DELAYED-RELEASE — Original Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved Breckenridge Pharmaceutical's original generic duloxetine hydrochloride delayed-release capsules, a generic version of the anti…

• FDA approval · 2014-06-09
  FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original ANDA for duloxetine hydrochloride, establishing a generic version of duloxetine.

• FDA approval · 2014-04-29
  FDA Approved: ROBAXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

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

• FDA approval · 2014-01-08
  FDA Approved: DULOXETINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for a duloxetine generic from Zydus Lifesciences Limited, enabling marketing for the same indications …

• FDA approval · 2013-12-17
  FDA Approved: DULOXETINE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s original application for a generic duloxetine product. The approval makes low-cost generic duloxetine av…

• FDA approval · 2013-12-11
  FDA Approved: DULOXETINE — Original Application (MARKSANS PHARMA LIMITED)

  FDA approves duloxetine hydrochloride generic by Marksans Pharma Limited under an Original ANDA (ANDA 090723).

• FDA approval · 2013-12-11
  FDA Approved: DULOXETINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' original application for a generic duloxetine product (DULOXETINE). This approval allows the mar…

• FDA approval · 2013-10-28
  FDA Approved: DICLOFENAC SODIUM — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal's Original Application for Diclofenac Sodium Tablets, a generic NSAID indicated for relief of pain and inflammation in s…

• FDA approval · 2013-07-30
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for cyclobenzaprine hydrochloride from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2013-06-07
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

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

• 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…