Muscle Spasticity

• FDA approval · 2024-12-17
  FDA Approved: DIAZEPAM — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  FDA approved a supplemental application for diazepam submitted by Lupin Pharmaceuticals, Inc. The approval relates to changes under the appr…

• FDA approval · 2024-04-25
  FDA Approved: DIAZEPAM — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's original application for a generic diazepam product. This approval supports a generic version…

• FDA approval · 2023-11-22
  FDA Approved: DIAZEPAM — Supplemental Application (Sunrise Pharmaceutical, Inc.)

  The FDA approved a supplemental application for Diazepam submitted by Sunrise Pharmaceutical, Inc.

• FDA approval · 2023-07-10
  FDA Approved: DIAZEPAM — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Diazepam from Oceanside Pharmaceuticals.

• FDA approval · 2022-06-10
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for a generic tizanidine hydrochloride product submitted by Alembic Pharmaceuticals Limited unde…

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• FDA approval · 2021-05-17
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for diazepam filed by Hikma Pharmaceuticals USA Inc., marking regulatory clearance for an additi…

• FDA approval · 2021-02-08
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for Diazepam (generic) from Natco Pharma USA LLC under an ANDA. The action confirms approval of the …

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Diazepam Intensol from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for diazepam from Hospira, Inc., under an ANDA, indicating regulatory approval of the requested chan…

• 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 · 2019-11-06
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  The FDA approved a supplemental application for Diazepam from Natco Pharma USA LLC, granting approval of generic diazepam under ANDA210363.

• FDA approval · 2019-02-21
  FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Diazepam filed by Hospira, Inc. (ANDA 072079).

• FDA approval · 2016-12-16
  FDA Approved: DIAZEPAM — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Diazepam from Oceanside Pharmaceuticals, resulting in changes to the drug's labeling.

• FDA approval · 2016-05-02
  FDA Approved: DIAZEPAM INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Diazepam Intensol from Hikma Pharmaceuticals USA Inc., confirming changes to the approved pr…

• FDA approval · 2016-03-24
  FDA Approved: DIAZEPAM — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application to Chartwell RX, LLC for diazepam oral solution (concentrate), authorizing a generic version of this…

• FDA approval · 2015-08-31
  FDA Approved: DANTROLENE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for dantrolene sodium from Amneal Pharmaceuticals of New York LLC (ANDA076856), allowing continued m…

• FDA approval · 2015-03-09
  FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a Teva supplemental application for Diazepam, resulting in an approved labeling change under ANDA 071321.

• 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., indicating an updated approval-related action for …

• FDA approval · 2008-07-23
  FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for diazepam filed by Teva Pharmaceuticals USA, Inc., updating/expanding its labeling.