Spinal Cord Injury

• FDA approval · 2021-04-30
  FDA Approved: BACLOFEN — Supplemental Application (Method Pharmaceuticals LLC)

  The FDA approved a supplemental application for Baclofen submitted by Method Pharmaceuticals LLC under ANDA212378. This action approves a su…

• FDA approval · 2021-03-05
  FDA Approved: BACLOFEN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for a generic baclofen (oral) by Rising Pharma Holdings, Inc. The approval covers use for management o…

• FDA approval · 2021-01-15
  FDA Approved: BACLOFEN — Original Application (MAlA Pharmaceuticals, Inc.)

  FDA approved the original application for baclofen, authorizing its marketing as a generic drug from MAlA Pharmaceuticals, Inc.

• FDA approval · 2020-11-03
  FDA Approved: BACLOFEN — Supplemental Application (Northstar RxLLC)

  The FDA approved a supplemental application for baclofen from Northstar RxLLC, finalizing changes to an approved generic product.

• FDA approval · 2020-10-22
  FDA Approved: TIZANIDINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for tizanidine from Dr. Reddy's Laboratories Limited.

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• FDA approval · 2020-10-09
  FDA Approved: BACLOFEN — Original Application (Method Pharmaceuticals LLC)

  FDA approved an original application for baclofen from Method Pharmaceuticals LLC, making a generic version available.

• FDA approval · 2020-08-13
  FDA Approved: BACLOFEN — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Baclofen from Endo USA, Inc. (ANDA077068).

• FDA approval · 2020-07-09
  FDA Approved: BACLOFEN — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved an original application for a generic baclofen product from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2020-05-27
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Trifluent Pharma, LLC)

  FDA approved the original application for tizanidine hydrochloride from Trifluent Pharma, LLC as a generic drug.

• FDA approval · 2020-03-24
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic version of tizanidine hydrochloride from Aurobindo Pharma Limited via Original Application (ANDA 213544) for the trea…

• FDA approval · 2019-09-18
  FDA Approved: BACLOFEN — Original Application (Palmetto Pharmaceuticals Inc.)

  FDA records an original application approval for Baclofen submitted by Palmetto Pharmaceuticals Inc. The document marks the approval of a Ba…

• FDA approval · 2019-09-11
  FDA Approved: BACLOFEN (INTRATHECAL) — Original Application (MAIA Pharmaceuticals, Inc.)

  FDA approved an original application for a generic intrathecal baclofen product from MAIA Pharmaceuticals, enabling marketing of intrathecal…

• FDA approval · 2019-07-30
  FDA Approved: BACLOFEN — Original Application (Sagent Pharmaceuticals)

  FDA approved baclofen from Sagent Pharmaceuticals under an original ANDA, confirming the availability of generic baclofen for treating muscl…

• FDA approval · 2019-07-19
  FDA Approved: PREGABALIN — Original Application (ScieGen Pharmaceuticals, Inc)

  FDA approves ScieGen Pharmaceuticals' original application for pregabalin (generic pregabalin), enabling the generic product to be marketed …

• FDA approval · 2019-03-27
  FDA Approved: TIZANIDNE HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)

  FDA approved Tizanidine Hydrochloride as an original generic drug application for the management of spasticity in adults with multiple scler…

• FDA approval · 2019-03-26
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved the original ANDA for tizanidine hydrochloride from Nivagen Pharmaceuticals, Inc.

• FDA approval · 2019-03-12
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Ingenus Pharmaceuticals' original application for a generic tizanidine hydrochloride product.

• FDA approval · 2019-01-25
  FDA Approved: TIZANIDINE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's original ANDA for tizanidine, establishing a generic version of the muscle relaxant.

• FDA approval · 2018-11-23
  FDA Approved: BACLOFEN — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the Original Application for Baclofen from Zydus Pharmaceuticals (USA) Inc., establishing a generic baclofen product. Baclofen …

• FDA approval · 2017-11-28
  FDA Approved: BACLOFEN — Original Application (TruPharma LLC)

  FDA approved the original ANDA for baclofen, a generic version produced by TruPharma LLC.

• FDA approval · 2017-03-03
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for a generic Tizanidine Hydrochloride from Zydus Lifesciences Limited.

• FDA approval · 2016-12-22
  FDA Approved: LIORESAL (BACLOFEN) — Supplemental Application (Amneal Pharmaceuticals LLC)

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

• FDA approval · 2016-09-30
  FDA Approved: LIORESAL (BACLOFEN) — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for LIORESAL (baclofen) from Amneal Pharmaceuticals LLC, signaling a change to the existing NDA.

• FDA approval · 2015-09-28
  FDA Approved: TIZANIDINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for tizanidine submitted by Apotex Corp.

• FDA approval · 2015-02-11
  FDA Approved: GABLOFEN — Supplemental Application (Piramal Critical Care Inc)

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