Post-traumatic Stress Disorder

• 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 · 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.

• FDA approval · 2015-11-17
  FDA Approved: PRAZOSIN HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for prazosin hydrochloride from Mylan Pharmaceuticals Inc., enabling the generic version to be m…

• 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 · 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.

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• 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 · 2014-11-07
  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 · 2014-10-27
  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 · 2014-09-12
  FDA Approved: ZOLOFT — Supplemental Application (ROERIG)

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

• 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.

• FDA approval · 2013-12-31
  FDA Approved: PAROXETINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Paroxetine hydrochloride hemihydrate from Mylan Pharmaceuticals, confirming the continued author…

• FDA approval · 2013-12-19
  FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for paroxetine submitted by Padagis US LLC (NDA 204516).

• FDA approval · 2013-12-16
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride (generic sertraline), enabling a new generic versi…

• FDA approval · 2013-09-26
  FDA Approved: ZOLOFT — Supplemental Application (ROERIG)

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

• FDA approval · 2013-06-28
  FDA Approved: PAROXETINE — Original Application (Padagis US LLC)

  FDA approved a paroxetine product from Padagis US LLC under an original application.

• FDA approval · 2013-02-01
  FDA Approved: ZOLOFT — Supplemental Application (ROERIG)

  FDA approved a supplemental application for ZOLOFT (sertraline hydrochloride) submitted by ROERIG.

• FDA approval · 2013-01-29
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for sertraline hydrochloride from Rising Pharma Holdings, Inc., indicating approval of changes to th…

• FDA approval · 2012-12-21
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for sertraline hydrochloride by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2012-12-18
  FDA Approved: PAXIL — Supplemental Application (Apotex Corp)

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

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

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

• 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 · 2011-08-19
  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.