Spasticity

• FDA approval · 2014-12-14
  FDA Approved: TIZANIDINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for a generic tizanidine product from Sun Pharmaceutical Industries under an ANDA. Tizanidine is…

• FDA approval · 2013-03-19
  FDA Approved: ZANAFLEX — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for ZANAFLEX (tizanidine hydrochloride) from Covis Pharma US, Inc.

• FDA approval · 2013-03-06
  FDA Approved: LIORESAL (BACLOFEN) — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Lioresal (baclofen) from Amneal Pharmaceuticals LLC, enabling changes to the product labeling fo…

• FDA approval · 2013-01-28
  FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for diazepam from Teva Pharmaceuticals USA, Inc. The action represents an additional approval or mod…

• FDA approval · 2013-01-17
  FDA Approved: GABLOFEN — Supplemental Application (Piramal Critical Care Inc)

  FDA approved a supplemental application for GABLOFEN (baclofen injection) from Piramal Critical Care Inc.

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• FDA approval · 2012-11-28
  FDA Approved: TIZANIDINE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s original abbreviated new drug application for tizanidine, a generic muscle relaxant. This…

• FDA approval · 2011-11-13
  FDA Approved: LIORESAL (BACLOFEN) — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Lioresal (baclofen) submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2010-04-27
  FDA Approved: BACLOFEN — Supplemental Application (Northstar RxLLC)

  The FDA approved a supplemental application for baclofen submitted by Northstar RxLLC. Baclofen is used to reduce muscle spasticity in condi…

• FDA approval · 2008-10-09
  FDA Approved: DANTRIUM — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for Dantrium (dantrolene sodium) from Par Health USA, LLC, under NDA 018264.

• FDA approval · 2006-07-28
  FDA Approved: ZANAFLEX — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for ZANAFLEX (tizanidine hydrochloride) submitted by Covis Pharma US, Inc.