Social Anxiety Disorder

• FDA approval · 2015-09-16
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for fluvoxamine maleate (generic) from Endo USA, Inc. under an ANDA.

• FDA approval · 2015-06-09
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for sertraline hydrochloride (generic) from Quallent Pharmaceuticals Health LLC under ANDA077397.

• FDA approval · 2015-05-28
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Yaopharma Co., Ltd.)

  FDA approved Yaopharma Co., Ltd.'s original application for venlafaxine hydrochloride, authorizing a new generic version of the antidepressa…

• FDA approval · 2015-05-01
  FDA Approved: VENLAFAXINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Venlafaxine from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. under an ANDA.

• FDA approval · 2014-12-17
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Effexor XR (venlafaxine hydrochloride) by Viatris Specialty LLC. The action is to modify labelin…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2014-12-01
  FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for paroxetine submitted by Padagis US LLC, adding or updating labeling under the existing NDA.

• FDA approval · 2014-11-26
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for PAROXETINE (paroxetine hydrochloride) from Zydus Lifesciences Limited, enabling the marketing of…

• FDA approval · 2014-11-17
  FDA Approved: VENLAFAXINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approval of a supplemental application for Venlafaxine from Sun Pharmaceutical Industries, confirming regulatory action on this generic …

• FDA approval · 2014-11-07
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Accord Healthcare, Inc.)

  FDA approves Accord Healthcare, Inc.'s generic sertraline hydrochloride under an Original Application (ANDA 202825).

• FDA approval · 2014-10-31
  FDA Approved: PAROXETINE — Original Application (Solco Healthcare US, LLC)

  FDA approved Solco Healthcare US, LLC's original ANDA for paroxetine hydrochloride hemihydrate (paroxetine), making a generic version of the…

• FDA approval · 2014-10-27
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride, a generic version of sertraline. This action …

• FDA approval · 2014-10-21
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Effexor XR (venlafaxine extended-release) submitted by Viatris Specialty LLC.

• FDA approval · 2014-09-19
  FDA Approved: VENLAFAXINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for venlafaxine by Alembic Pharmaceuticals, enabling a generic venlafaxine product through an ANDA s…

• FDA approval · 2014-09-12
  FDA Approved: ZOLOFT — Supplemental Application (ROERIG)

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

• FDA approval · 2014-07-17
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for venlafaxine hydrochloride from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2014-07-17
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for venlafaxine hydrochloride (generic) from Dr. Reddy's Laboratories Limited. This action approves …

• FDA approval · 2014-07-17
  FDA Approved: VENLAFAXINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals' supplemental application for a generic venlafaxine product (ANDA 078932). Venlafaxine is indicated…

• FDA approval · 2014-07-17
  FDA Approved: VENLAFAXINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Venlafaxine hydrochloride, a generic venlafaxine product from Aurobindo Pharma Limited.

• FDA approval · 2014-06-30
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for venlafaxine hydrochloride from Teva Pharmaceuticals USA, Inc., marking an approval action un…

• FDA approval · 2014-06-26
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

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

• FDA approval · 2014-06-26
  FDA Approved: VENLAFAXINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for venlafaxine submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

• FDA approval · 2014-06-18
  FDA Approved: VENLAFAXINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Venlafaxine hydrochloride from Aurobindo Pharma Limited.

• FDA approval · 2014-06-17
  FDA Approved: VENLAFAXINE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for venlafaxine from BluePoint Laboratories under ANDA077653. This action authorizes a generic versi…

• FDA approval · 2014-01-10
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for venlafaxine hydrochloride from Zydus Pharmaceuticals USA Inc., authorizing its manufacturing and…

• FDA approval · 2013-12-31
  FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)

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