Social Anxiety Disorder

• FDA approval · 2017-12-19
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Vertical Pharmaceuticals, LLC)

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

• FDA approval · 2017-12-08
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for sertraline hydrochloride submitted by Mylan Pharmaceuticals, likely affecting the product la…

• FDA approval · 2017-10-05
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves Macleods Pharmaceuticals Limited's venlafaxine hydrochloride original application (generic), expanding access to treatment for …

• FDA approval · 2017-08-18
  FDA Approved: PAROXETINE — Original Application (Solco Healthcare LLC)

  FDA approves the original generic application for Paroxetine (Solco Healthcare LLC).

• FDA approval · 2017-08-03
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Sertraline Hydrochloride submitted by Rising Pharma Holdings, Inc.

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• FDA approval · 2017-06-15
  FDA Approved: ZOLOFT — Supplemental Application (ROERIG)

  FDA approved a supplemental application for ZOLOFT (sertraline hydrochloride) submitted by ROERIG, indicating an approved modification to th…

• FDA approval · 2017-04-28
  FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)

  The FDA has approved a supplemental application for paroxetine filed by Padagis US LLC. This notice indicates FDA approval of an amendment t…

• FDA approval · 2017-03-24
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved a generic venlafaxine hydrochloride product from Westminster Pharmaceuticals, LLC under an Original Application. This approval …

• FDA approval · 2017-01-20
  FDA Approved: PAROXETINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for Paroxetine, a generic selective serotonin reuptake inhibitor. The approval expa…

• FDA approval · 2017-01-04
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Vertical Pharmaceuticals, LLC)

  The FDA approved a supplemental application for venlafaxine hydrochloride from Vertical Pharmaceuticals, LLC, likely related to labeling cha…

• FDA approval · 2017-01-04
  FDA Approved: VENLAFAXINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Venlafaxine from Sun Pharmaceutical Industries, Inc., indicating approval of a change to the exi…

• FDA approval · 2017-01-04
  FDA Approved: VENLAFAXINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental ANDA for venlafaxine by Heritage Pharmaceuticals (Avet) to bring a generic version to the market.

• FDA approval · 2017-01-04
  FDA Approved: VENLAFAXINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for venlafaxine hydrochloride (generic venlafaxine) from Aurobindo Pharma Limited.

• FDA approval · 2017-01-04
  FDA Approved: VENLAFAXINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for Venlafaxine from Alembic Pharmaceuticals Inc. under an approved ANDA.

• FDA approval · 2017-01-04
  FDA Approved: VENLAFAXINE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application from BluePoint Laboratories for Venlafaxine (venlafaxine hydrochloride), a generic antidepressan…

• FDA approval · 2017-01-04
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2016-12-23
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for sertraline hydrochloride (generic) manufactured by Mylan Pharmaceuticals Inc.; this represen…

• FDA approval · 2016-11-25
  FDA Approved: VENLAFAXINE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for a venlafaxine hydrochloride generic product from BluePoint Laboratories under ANDA077653. Th…

• FDA approval · 2016-06-21
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Vertical Pharmaceuticals, LLC)

  FDA approved a supplemental application for venlafaxine hydrochloride (Vertical Pharmaceuticals, LLC). This action expands the sponsor's NDA…

• FDA approval · 2016-06-10
  FDA Approved: PAROXETINE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original ANDA for paroxetine (paroxetine hydrochloride), establishing a generic version of the antidepr…

• FDA approval · 2016-03-14
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for sertraline hydrochloride from Aurobindo Pharma Limited, enabling the commercialization of a gene…

• FDA approval · 2016-02-29
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2016-01-26
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for venlafaxine hydrochloride from Aurobindo Pharma Limited.

• FDA approval · 2016-01-20
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for venlafaxine hydrochloride submitted by Zydus Pharmaceuticals USA Inc., resulting in regulatory a…

• FDA approval · 2015-12-23
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for sertraline hydrochloride (Lupin Pharmaceuticals, Inc.), a generic product under an ANDA.