Panic Disorder

• 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 · 2016-01-12
  FDA Approved: FLUOXETINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for fluoxetine from Alembic Pharmaceuticals Limited.

• 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.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2015-11-24
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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

• FDA approval · 2015-07-31
  FDA Approved: ALPRAZOLAM — Original Application (Aurobindo Pharma Limited)

  The FDA approves Aurobindo Pharma Limited's generic alprazolam through an original ANDA submission, authorizing market entry of the generic …

• 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 · 2015-05-18
  FDA Approved: CLONAZEPAM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s Supplemental Application for clonazepam, making a supplemental approval under the approved ANDA. Clona…

• 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 · 2015-03-16
  FDA Approved: FLUOXETINE — Original Application (Vensun Pharmaceuticals, Inc.)

  The FDA approved Vensun Pharmaceuticals' original (ANDA) application for fluoxetine hydrochloride, establishing a generic fluoxetine product…

• FDA approval · 2015-02-03
  FDA Approved: KLONOPIN — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for KLONOPIN (clonazepam) filed by H2-Pharma, LLC.

• FDA approval · 2015-01-12
  FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved a supplemental application for a generic fluoxetine product (ANDA 076458) from Chartwell Governmental & Specialty RX, LLC. This…

• 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…

• 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: ALPRAZOLAM — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Alprazolam submitted by Sandoz Inc, related to a generic version of the drug.

• 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 · 2014-10-17
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for fluoxetine.

• FDA approval · 2014-10-10
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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