Panic Disorder

• FDA approval · 2021-05-03
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved the original application for sertraline hydrochloride generic by XLCare Pharmaceuticals, enabling a generic version to be marke…

• FDA approval · 2021-04-19
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc., updating the generic's labeling under the AN…

• FDA approval · 2021-03-01
  FDA Approved: XANAX XR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for XANAX XR (alprazolam) filed by Viatris Specialty LLC.

• FDA approval · 2021-02-16
  FDA Approved: PAROXETINE — Original Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals' generic paroxetine (PAROXETINE) via an Original Application (ANDA213485). It covers indication…

• FDA approval · 2021-02-06
  FDA Approved: PAXIL — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for Paxil (paroxetine hydrochloride) submitted by Apotex Corp.

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• FDA approval · 2021-02-05
  FDA Approved: ALPRAZOLAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Alprazolam submitted by Mylan Pharmaceuticals, contributing to the existing approval for thi…

• FDA approval · 2021-02-05
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for clonazepam from Teva Pharmaceuticals USA, Inc., to modify labeling.

• FDA approval · 2021-02-05
  FDA Approved: XANAX XR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for XANAX XR (alprazolam) from Viatris Specialty LLC. The action involves changes to the product…

• FDA approval · 2021-02-05
  FDA Approved: CLONAZEPAM — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for clonazepam from Alembic Pharmaceuticals Inc., bringing a generic clonazepam product to market.

• FDA approval · 2021-02-05
  FDA Approved: ALPRAZOLAM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for alprazolam by Actavis Pharma, Inc., enabling a generic alprazolam product.

• FDA approval · 2021-01-22
  FDA Approved: CLONAZEPAM — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for clonazepam from Par Health USA, LLC under an ANDA, signaling approval of a supplemental fili…

• FDA approval · 2021-01-21
  FDA Approved: FLUOXETINE — Supplemental Application (Alembic Pharmaceuticals Limited)

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

• FDA approval · 2020-12-23
  FDA Approved: FLUOXETINE — Supplemental Application (Cadila Pharmaceuticals Limited)

  FDA approved a supplemental application for Fluoxetine from Cadila Pharmaceuticals Limited, enabling the marketing of this generic fluoxetin…

• FDA approval · 2020-11-03
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for venlafaxine hydrochloride (generic) under ANDA076565, enabling it…

• FDA approval · 2020-10-21
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved the generic venlafaxine hydrochloride (venlafaxine) under Original Application for the treatment of major depressive disorder, …

• FDA approval · 2020-08-07
  FDA Approved: CLOMIPRAMINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for clomipramine hydrochloride (generic) from Rising Pharma Holdings, Inc., enabling a generic product…

• FDA approval · 2020-07-21
  FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Paroxetine hydrochloride from Apotex Corp., enabling continued marketing of a generic product.

• FDA approval · 2020-06-10
  FDA Approved: FLUOXETINE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's generic fluoxetine through an Original Application (ANDA).

• FDA approval · 2020-04-28
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

  The FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company.

• FDA approval · 2020-04-14
  FDA Approved: VENLAFAXINE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for venlafaxine by BluePoint Laboratories, expanding its generic availability.

• FDA approval · 2020-04-14
  FDA Approved: VENLAFAXINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Venlafaxine hydrochloride (generic Venlafaxine) by Aurobindo Pharma Limited.

• FDA approval · 2020-04-10
  FDA Approved: VENLAFAXINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for venlafaxine from Alembic Pharmaceuticals.

• FDA approval · 2020-04-08
  FDA Approved: FLUOXETINE — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic fluoxetine product from Aurobindo Pharma Limited under an Original Application (ANDA 213286). Fluoxetine is an SSRI i…

• FDA approval · 2020-03-12
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Advagen Pharma Ltd.)

  FDA approved the original application for venlafaxine hydrochloride by Advagen Pharma Ltd., authorizing a generic version of this antidepres…

• FDA approval · 2020-02-21
  FDA Approved: SERTRALINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for sertraline from Heritage Pharmaceuticals (d/b/a Avet), signaling approval of a change or additio…