Panic Disorder

• FDA approval · 2012-07-31
  FDA Approved: VENLAFAXINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for venlafaxine by Alembic Pharmaceuticals Inc. to support a generic version of the antidepressant. …

• FDA approval · 2012-07-31
  FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for a generic paroxetine hydrochloride product submitted by NorthStar Rx LLC.

• FDA approval · 2012-07-31
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited, authorizing its marketing as a gen…

• FDA approval · 2012-06-26
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical’s supplemental application for venlafaxine hydrochloride, a generic product. The approval relates to the sta…

• FDA approval · 2012-05-03
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

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

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• FDA approval · 2012-05-02
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Vertical Pharmaceuticals, LLC)

  The FDA approved a supplemental application for venlafaxine hydrochloride (Vertical Pharmaceuticals, LLC) to update the product labeling und…

• FDA approval · 2012-04-19
  FDA Approved: FLUOXETINE — Supplemental Application (TIME CAP LABORATORIES, INC.)

  FDA approved a supplemental application for fluoxetine hydrochloride from Time Cap Laboratories, Inc., updating the regulatory status of thi…

• FDA approval · 2012-04-10
  FDA Approved: PAROXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)

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

• FDA approval · 2012-02-28
  FDA Approved: FLUOXETINE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approves a supplemental application for a generic fluoxetine hydrochloride product from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2012-02-28
  FDA Approved: FLUOXETINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves the supplemental application for fluoxetine from Alembic Pharmaceuticals Limited, enabling the generic fluoxetine product to be…

• FDA approval · 2011-12-27
  FDA Approved: PAROXETINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application from Mylan Pharmaceuticals for paroxetine hydrochloride hemihydrate, authorizing a generic version o…

• FDA approval · 2011-12-15
  FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Apotex Corp. to manufacture and market paroxetine hydrochloride as a generic antidepressant.

• FDA approval · 2011-12-08
  FDA Approved: ALPRAZOLAM — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for alprazolam submitted by Actavis Pharma, Inc., resulting in changes to the product labeling.

• FDA approval · 2011-11-22
  FDA Approved: FLUOXETINE — Supplemental Application (TIME CAP LABORATORIES, INC.)

  FDA approved a supplemental application for fluoxetine hydrochloride from Time Cap Laboratories, Inc., enabling the generic product Fluoxeti…

• FDA approval · 2011-11-22
  FDA Approved: ALPRAZOLAM EXTENDED RELEASE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Alprazolam Extended Release, authorizing an extended-release formulation of alprazolam by Actavi…

• FDA approval · 2011-09-27
  FDA Approved: ALPRAZOLAM — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for alprazolam (generic) under Par Health USA, LLC.

• FDA approval · 2011-09-15
  FDA Approved: CLONAZEPAM — Supplemental Application (Solco Healthcare LLC)

  FDA approved Solco Healthcare LLC's supplemental application for clonazepam under an approved ANDA.

• FDA approval · 2011-08-23
  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 · 2011-08-23
  FDA Approved: ALPRAZOLAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for alprazolam from Mylan Pharmaceuticals Inc., affecting the generic product's labeling.

• FDA approval · 2011-08-19
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for SERTRALINE HYDROCHLORIDE (Mylan Pharmaceuticals Inc.), indicating regulatory action on this gene…

• FDA approval · 2011-07-27
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride (paroxetine) from Zydus Lifesciences Limited under an ANDA.

• FDA approval · 2011-06-07
  FDA Approved: ALPRAZOLAM — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic alprazolam product from Aurobindo Pharma Limited under an Original Application (ANDA).

• FDA approval · 2011-06-01
  FDA Approved: ALPRAZOLAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Alprazolam from Mylan Pharmaceuticals, authorizing a generic alprazolam product. The approva…

• FDA approval · 2011-05-06
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved the original ANDA for Venlafaxine hydrochloride by Dr. Reddy's Laboratories Inc, enabling a generic version of this antidepress…

• FDA approval · 2011-04-14
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for venlafaxine hydrochloride from Zydus Pharmaceuticals USA Inc., authorizing a generic version of the antid…