Panic Disorder

• FDA approval · 2023-03-30
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA granted supplemental approval for a generic venlafaxine hydrochloride product from Aurobindo Pharma Limited.

• FDA approval · 2023-03-23
  FDA Approved: PAROXETINE — Supplemental Application (Modavar Pharmaceuticals LLC)

  FDA approved a supplemental application for generic paroxetine filed by Modavar Pharmaceuticals LLC under ANDA212645.

• FDA approval · 2023-01-31
  FDA Approved: PAROXETINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for paroxetine from ANI Pharmaceuticals, indicating an approved change to the product (e.g., lab…

• FDA approval · 2023-01-25
  FDA Approved: ZOLOFT — Supplemental Application (ROERIG)

  The FDA approved a supplemental application for Zoloft (sertraline hydrochloride) filed by Roerig.

• FDA approval · 2023-01-17
  FDA Approved: ALPRAZOLAM — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Alprazolam by Par Health USA, LLC. This action likely updates labeling or expands the indica…

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• FDA approval · 2023-01-17
  FDA Approved: CLONAZEPAM — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for clonazepam submitted by Par Health USA, LLC, supporting continued use of this generic benzod…

• 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: ALPRAZOLAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for alprazolam from Mylan Pharmaceuticals Inc., indicating a revised or expanded approval under an N…

• FDA approval · 2022-12-05
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA has approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride, allowing the generic to be marketed as part o…

• FDA approval · 2022-11-29
  FDA Approved: ESCITALOPRAM OXALATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for escitalopram oxalate (a generic version of Lexapro), enabling market entry…

• FDA approval · 2022-11-28
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approves the original application for venlafaxine hydrochloride tablets from Rising Pharma Holdings, Inc., making a generic version …

• FDA approval · 2022-11-21
  FDA Approved: VENLAFAXINE — Supplemental Application (Ascend Laboratories, LLC)

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

• FDA approval · 2022-11-15
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith's fluoxetine hydrochloride as an original generic application, allowing the generic product to be marketed wit…

• FDA approval · 2022-11-09
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approves ANI Pharmaceuticals' original application for fluoxetine hydrochloride, a generic version of fluoxetine.

• FDA approval · 2022-08-30
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride as a generic, confirming approval under the ANDA p…

• FDA approval · 2022-08-30
  FDA Approved: VENLAFAXINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application (ANDA) for venlafaxine from Zydus Lifesciences Limited, enabling generic access to the antidepressant.

• FDA approval · 2022-08-15
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Effexor XR (venlafaxine hydrochloride) from Viatris Specialty LLC.

• FDA approval · 2022-08-09
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Venlafaxine Hydrochloride (extended-release) submitted by Chartwell RX, LLC.

• FDA approval · 2022-06-29
  FDA Approved: VENLAFAXINE — Original Application (Almatica Pharma LLC)

  The FDA approved an Original Application for Venlafaxine from Almatica Pharma LLC. Venlafaxine is indicated for major depressive disorder, g…

• FDA approval · 2022-03-29
  FDA Approved: FLUOXETINE — Original Application (Micro Labs Limited)

  The FDA approved Micro Labs Limited's original application for a generic fluoxetine product.

• FDA approval · 2022-02-25
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited, applying to the generic product.

• FDA approval · 2022-01-19
  FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)

  The FDA granted a supplemental approval for paroxetine hydrochloride (paroxetine) from NorthStar Rx LLC under an ANDA. This approval confirm…

• FDA approval · 2021-11-02
  FDA Approved: PAROXETINE — Original Application (Chartwell RX, LLC.)

  FDA approved a generic paroxetine product under an original ANDA submitted by Chartwell RX, LLC.

• FDA approval · 2021-10-04
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Alvogen, Inc.)

  FDA approves the sertraline hydrochloride generic under an Original Application filed by Alvogen, Inc. The approval enables marketing of a g…

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for Fluoxetine Hydrochloride from Lannett Company, Inc., a generic fluoxetine product.