Anxiety Disorders

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

  FDA approves a supplemental application for Diazepam by Natco Pharma USA LLC, approving a supplemental change to the generic diazepam produc…

• FDA approval · 2023-01-17
  FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2023-01-17
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for diazepam submitted by Hikma Pharmaceuticals USA Inc., marking regulatory action to support t…

• FDA approval · 2023-01-17
  FDA Approved: DIAZEPAM — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for diazepam oral solution concentrate from Chartwell RX, LLC, adding/confirming approval for this d…

• FDA approval · 2023-01-17
  FDA Approved: OXAZEPAM — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Oxazepam (generic) submitted by Actavis Pharma, Inc. (ANDA072253).

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• FDA approval · 2023-01-17
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Diazepam from Hikma Pharmaceuticals USA Inc., indicating an update to an existing Diazepam produ…

• FDA approval · 2023-01-17
  FDA Approved: CLONAZEPAM — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for clonazepam, confirming approval of a generic clonazepam product.

• FDA approval · 2023-01-13
  FDA Approved: ATIVAN — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for ATIVAN (lorazepam) submitted by Bausch Health US LLC. The action indicates a label update or…

• FDA approval · 2023-01-13
  FDA Approved: LOREEV XR — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental application for LOREEV XR (lorazepam) submitted by Almatica Pharma LLC.

• FDA approval · 2023-01-13
  FDA Approved: VALIUM — Supplemental Application (Roche Laboratories Inc.)

  The FDA approved a supplemental application for Valium (diazepam) from Roche Laboratories Inc., updating the existing NDA.

• FDA approval · 2023-01-11
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for diazepam (generic) from Natco Pharma USA LLC under ANDA210363.

• FDA approval · 2022-11-10
  FDA Approved: DIAZEPAM — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's Original Application for diazepam (generic diazepam). This approval adds a new generic option for…

• FDA approval · 2022-08-09
  FDA Approved: LORAZEPAM — Supplemental Application (International Medication Systems, Limited)

  FDA approves a supplemental application for Lorazepam submitted by International Medication Systems, Limited, enabling its generic formulati…

• FDA approval · 2022-06-16
  FDA Approved: CLORAZEPATE DIPOTASSIUM — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' original application for a generic clorazepate dipotassium product.

• FDA approval · 2022-02-09
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (First Nation Group, LLC)

  FDA approved the original application for a generic doxepin hydrochloride product from First Nation Group, LLC, enabling its marketing in th…

• FDA approval · 2022-02-02
  FDA Approved: CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE — Original Application (Micro Labs Limited)

  FDA approved the original application for CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (ANDA 211925) from Micro Labs Limited.

• FDA approval · 2021-11-12
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Diazepam from Hikma Pharmaceuticals USA Inc. under an ANDA, reflecting a regulatory action on th…

• FDA approval · 2021-06-23
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved Natco Pharma USA LLC's supplemental application for Diazepam (generic).

• 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 · 2021-02-16
  FDA Approved: HYDROXYZINE PAMOATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for hydroxyzine pamoate.

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

  FDA approved a supplemental application for Diazepam from Natco Pharma USA LLC (ANDA 211998). This action confirms the continued approval/av…

• FDA approval · 2021-02-05
  FDA Approved: CHLORDIAZEPOXIDE HYDROCHLORIDE — Supplemental Application (Epic Pharma LLC)

  FDA approved a supplemental application for chlordiazepoxide hydrochloride from Epic Pharma LLC. The approval pertains to the generic produc…

• 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 · 2021-02-05
  FDA Approved: OXAZEPAM — Supplemental Application (TruPharma, LLC)

  FDA approved a supplemental application for Oxazepam from TruPharma, LLC.