Spasticity

• FDA approval · 2025-12-16
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental abbreviated new drug application for tizanidine hydrochloride (generic tizanidine).

• FDA approval · 2025-11-21
  FDA Approved: BACLOFEN — Supplemental Application (Medcore LLC)

  FDA approved Medcore LLC's supplemental application for Baclofen (ANDA 214099).

• FDA approval · 2025-06-03
  FDA Approved: BACLOFEN — Supplemental Application (Advagen Pharma Ltd)

  FDA approves a supplemental application for Baclofen from Advagen Pharma Ltd.

• FDA approval · 2025-06-03
  FDA Approved: BACLOFEN — Supplemental Application (Method Pharmaceuticals LLC)

  The FDA approved a supplemental application for baclofen from Method Pharmaceuticals LLC.

• FDA approval · 2025-03-03
  FDA Approved: TIZANIDINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for tizanidine submitted by Apotex Corp. This action approves the changes described in the supplemen…

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• FDA approval · 2024-12-06
  FDA Approved: BACLOFEN — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's Baclofen Original Application, confirming a generic Baclofen product for approved indications.

• FDA approval · 2023-10-11
  FDA Approved: VALIUM — Supplemental Application (Roche Laboratories Inc.)

  FDA approved a Supplemental Application for Valium (diazepam) from Roche Laboratories Inc., indicating an approved change or addition to the…

• FDA approval · 2023-02-22
  FDA Approved: BACLOFEN — Original Application (Nexus Pharmaceuticals LLC)

  FDA approves Nexus Pharmaceuticals LLC's original ANDA for baclofen, a generic treatment for spasticity conditions.

• FDA approval · 2023-02-08
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved Natco Pharma USA LLC's supplemental application for Diazepam (generic) under ANDA210363. This approval advances the generic Dia…

• FDA approval · 2022-05-31
  FDA Approved: GABLOFEN — Supplemental Application (Piramal Critical Care Inc)

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

• FDA approval · 2021-11-22
  FDA Approved: LYVISPAH — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved LYVISPAH (baclofen) from Amneal Pharmaceuticals LLC as an Original Application. It is indicated for the management of spasticit…

• FDA approval · 2021-09-22
  FDA Approved: BACLOFEN — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for baclofen from Chartwell RX, LLC, under ANDA077241, indicating regulatory approval of this supple…

• 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 · 2020-07-09
  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 · 2020-03-24
  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 · 2019-12-26
  FDA Approved: DIAZEPAM — Original Application (Natco Pharma USA LLC)

  FDA approved Natco Pharma USA LLC's original application for a generic diazepam product, enabling its marketing in the United States.

• 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 · 2019-03-27
  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 · 2017-03-03
  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 · 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.