Panic Disorder

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved a supplemental application for fluoxetine submitted by Chartwell Governmental & Specialty RX, LLC.

• FDA approval · 2021-09-21
  FDA Approved: VENLAFAXINE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Venlafaxine (venlafaxine hydrochloride) from BluePoint Laboratories, confirming the approval of …

• FDA approval · 2021-09-21
  FDA Approved: VENLAFAXINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for venlafaxine from Sun Pharmaceutical Industries (ANDA078627).

• FDA approval · 2021-09-21
  FDA Approved: VENLAFAXINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic Venlafaxine manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceutica…

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for fluoxetine hydrochloride submitted by PAI Holdings, LLC dba PAI Pharma. The approval updates the…

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• FDA approval · 2021-09-21
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for venlafaxine hydrochloride from Teva Pharmaceuticals USA, Inc. The approval pertains to changes t…

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for fluoxetine submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2021-09-20
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

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

• FDA approval · 2021-09-20
  FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)

  The FDA approved a supplemental application for fluoxetine from Saptalis Pharmaceuticals, LLC., enabling a generic fluoxetine product under …

• FDA approval · 2021-09-20
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fluoxetine from Aurobindo Pharma Limited, granting approval of a generic fluoxetine product.

• FDA approval · 2021-09-20
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Vertical Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Venlafaxine hydrochloride from Vertical Pharmaceuticals, LLC.

• FDA approval · 2021-09-20
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for fluoxetine hydrochloride, enabling marketing of a generic fluoxetine produc…

• FDA approval · 2021-09-03
  FDA Approved: VENLAFAXINE — Supplemental Application (Cadila Pharmaceuticals Limited)

  FDA approved a supplemental application for Venlafaxine from Cadila Pharmaceuticals Limited.

• FDA approval · 2021-09-03
  FDA Approved: VENLAFAXINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for venlafaxine (generic) from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., approv…

• FDA approval · 2021-09-03
  FDA Approved: PAROXETINE — Original Application (ANI Pharmaceuticals, Inc.)

  ANI Pharmaceuticals received FDA approval for an original ANDA application for paroxetine, a generic antidepressant.

• FDA approval · 2021-09-02
  FDA Approved: VENLAFAXINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for venlafaxine by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2021-09-01
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for fluoxetine hydrochloride from Dr. Reddy's Laboratories Limited (ANDA 078572), updating regulator…

• FDA approval · 2021-08-31
  FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)

  FDA approved a supplemental application for fluoxetine from Saptalis Pharmaceuticals, confirming the availability of a generic fluoxetine pr…

• FDA approval · 2021-08-27
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for a fluoxetine hydrochloride generic product from PAI Holdings (PAI Pharma). This action approves …

• FDA approval · 2021-08-27
  FDA Approved: PAROXETINE — Original Application (Modavar Pharmaceuticals LLC)

  FDA approved a generic paroxetine tablet product from Modavar Pharmaceuticals LLC under an original abbreviated new drug application (ANDA 2…

• FDA approval · 2021-08-25
  FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

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

• FDA approval · 2021-08-06
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Epic Pharma, LLC)

  FDA approved the original application for Venlafaxine hydrochloride (generic) manufactured by Epic Pharma, LLC.

• FDA approval · 2021-06-30
  FDA Approved: VENLAFAXINE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original application for venlafaxine from Dr. Reddy's Laboratories, making a generic version of the antidepressant availabl…

• FDA approval · 2021-06-16
  FDA Approved: ALPRAZOLAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Alprazolam from Hikma Pharmaceuticals USA Inc. (generic alprazolam).

• FDA approval · 2021-06-10
  FDA Approved: VENLAFAXINE — Original Application (Ascend Laboratories, LLC)

  FDA approved a generic venlafaxine product from Ascend Laboratories, LLC under Original Application (ANDA).