Panic Disorder

• 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 · 2024-04-05
  FDA Approved: FLUOXETINE — Original Application (Strides Pharma Science Limited)

  FDA approved an Original Application for a generic Fluoxetine from Strides Pharma Science Limited, enabling a generic version of fluoxetine …

• 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 · 2024-02-02
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for sertraline hydrochloride from Rising Pharma Holdings, Inc., resulting in approval of a gener…

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• 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 · 2024-01-19
  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 · 2024-01-09
  FDA Approved: FLUOXETINE — Supplemental Application (Vensun Pharmaceuticals, Inc.)

  FDA approved a supplemental application for fluoxetine hydrochloride from Vensun Pharmaceuticals, Inc., granting approval of a generic fluox…

• 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 · 2024-01-03
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for fluoxetine hydrochloride.

• FDA approval · 2023-12-19
  FDA Approved: FLUOXETINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for fluoxetine by Alembic Pharmaceuticals Limited.

• 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 · 2023-11-20
  FDA Approved: FLUOXETINE — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for fluoxetine submitted by Endo USA, Inc., resulting in regulatory changes to the product's sta…

• FDA approval · 2023-11-15
  FDA Approved: FLUOXETINE — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for fluoxetine (generic) from Micro Labs Limited under an ANDA.

• 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…

• FDA approval · 2023-09-22
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved a supplemental application for sertraline hydrochloride from Granules Pharmaceuticals Inc. The action confirms continued approv…

• FDA approval · 2023-09-19
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for fluoxetine submitted by Aurobindo Pharma Limited. This action updates the regulatory status …

• FDA approval · 2023-08-21
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for fluoxetine hydrochloride (generic fluoxetine) submitted by PAI Holdings, dba PAI Pharma.

• FDA approval · 2023-08-21
  FDA Approved: VENLAFAXINE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Venlafaxine from BluePoint Laboratories, confirming a generic venlafaxine product (venlafaxine h…

• FDA approval · 2023-08-21
  FDA Approved: VENLAFAXINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for Venlafaxine from Sun Pharmaceutical Industries, Inc., updating the generic product under ANDA 07…

• FDA approval · 2023-08-21
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for fluoxetine hydrochloride (ANI Pharmaceuticals, Inc.), indicating approval of changes to an alrea…

• FDA approval · 2023-08-18
  FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

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

• FDA approval · 2023-08-18
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sertraline hydrochloride (generic) manufactured by Mylan Pharmaceuticals Inc.