Generalized Anxiety Disorder

• FDA approval · 2024-08-12
  FDA Approved: VENLAFAXINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for venlafaxine submitted by Ascend Laboratories, LLC.

• FDA approval · 2024-07-26
  FDA Approved: BUSPIRONE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2024-07-11
  FDA Approved: PREGABALIN — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  FDA approved ScieGen Pharmaceuticals' generic pregabalin product through an abbreviated new drug application.

• FDA approval · 2024-06-06
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' Venlafaxine hydrochloride as an original-application generic (ANDA 217767). Venlafaxine HCl is indicat…

• FDA approval · 2024-06-05
  FDA Approved: PREGABALIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves the supplemental ANDA for pregabalin from Aurobindo Pharma Limited, enabling the marketing of a generic pregabalin product in t…

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• FDA approval · 2024-05-30
  FDA Approved: ESCITALOPRAM OXALATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental application for escitalopram oxalate, enabling a generic version to be marketed.

• FDA approval · 2024-04-19
  FDA Approved: LEXAPRO — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Lexapro (escitalopram) submitted by Allergan, Inc., advancing a labeling action for the product.

• FDA approval · 2024-04-15
  FDA Approved: ESCITALOPRAM OXALATE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for escitalopram oxalate from Amneal Pharmaceuticals LLC, approving a generic version of escital…

• FDA approval · 2024-04-11
  FDA Approved: ALPRAZOLAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for alprazolam submitted by Aurobindo Pharma Limited under an ANDA. This action indicates approval o…

• FDA approval · 2024-03-21
  FDA Approved: ESCITALOPRAM ORAL SOLUTION — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for escitalopram oral solution from Chartwell RX, LLC, recognizing a generic formulation.

• FDA approval · 2024-03-19
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for venlafaxine hydrochloride from Camber Pharmaceuticals, approving a new supplement to an existing…

• FDA approval · 2024-03-15
  FDA Approved: ALPRAZOLAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals LLC's supplemental application for Alprazolam (generic) under ANDA078387, signaling a supplemental appro…

• FDA approval · 2024-03-08
  FDA Approved: ESCITALOPRAM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for escitalopram oxalate (escitalopram) by Sun Pharmaceutical Industries, enabling marketing of the …

• FDA approval · 2024-02-05
  FDA Approved: ESCITALOPRAM — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for escitalopram from Macleods Pharmaceuticals Limited, authorizing changes to the product labeling.

• FDA approval · 2024-02-05
  FDA Approved: ESCITALOPRAM OXALATE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Escitalopram Oxalate (escitalopram) by Exelan Pharmaceuticals Inc. under ANDA078604.

• FDA approval · 2024-01-30
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Epic Pharma, LLC)

  The FDA approved a supplemental application for venlafaxine hydrochloride from Epic Pharma, LLC, supporting the approval of a generic produc…

• FDA approval · 2024-01-24
  FDA Approved: PREGABALIN — Supplemental Application (MARKSANS PHARMA LIMITED)

  FDA approved a supplemental application for pregabalin submitted by Marksans Pharma Limited (ANDA 216197).

• FDA approval · 2024-01-19
  FDA Approved: PAROXETINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Paroxetine by ANI Pharmaceuticals, Inc., indicating approval of a generic product under ANDA 215…

• FDA approval · 2024-01-16
  FDA Approved: DOXEPIN — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for the generic doxepin from Actavis Pharma, Inc., adding regulatory authorization for this prod…

• FDA approval · 2024-01-03
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for venlafaxine hydrochloride from Aurobindo Pharma Limited, confirming approval of the generic prod…

• FDA approval · 2023-12-19
  FDA Approved: DULOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for duloxetine hydrochloride from Aurobindo Pharma Limited, granting regulatory clearance for a gene…

• FDA approval · 2023-11-21
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for venlafaxine hydrochloride extended-release (Chartwell RX, LLC), reflecting an approved update to…

• FDA approval · 2023-11-21
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  The FDA approved a supplemental application for venlafaxine hydrochloride from Granules Pharmaceuticals Inc., authorizing an additional form…

• FDA approval · 2023-11-01
  FDA Approved: VENLAFAXINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA granted supplemental approval for venlafaxine from Zydus Lifesciences Limited, signaling an approved modification to an existing generic…

• FDA approval · 2023-10-18
  FDA Approved: ALPRAZOLAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for Alprazolam from Natco Pharma USA LLC under an ANDA, updating the regulatory status of the produc…