Premenstrual Dysphoric Disorder

• FDA approval · 2016-10-21
  FDA Approved: FLUOXETINE — Original Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's original application for fluoxetine, authorizing the marketing of a generic fluoxetine pr…

• FDA approval · 2016-08-19
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Endo USA, Inc.)

  FDA approves Endo USA, Inc.'s fluoxetine hydrochloride as an Original Application, providing a generic version of fluoxetine hydrochloride.

• FDA approval · 2016-08-01
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

  FDA approves a supplemental application for PROZAC (fluoxetine hydrochloride) submitted by Dista Products Company.

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

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

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• 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 · 2015-11-24
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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

• FDA approval · 2015-06-09
  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 · 2015-03-16
  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 · 2015-01-12
  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 · 2014-12-01
  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 · 2014-11-07
  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 · 2014-10-10
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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

• 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 · 2014-09-11
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approves a supplemental application for Fluoxetine hydrochloride (fluoxetine) from PAI Holdings, LLC dba PAI Pharma.

• FDA approval · 2014-08-11
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for a fluoxetine hydrochloride generic product submitted by PAI Holdings (PAI Pharma).

• FDA approval · 2014-07-18
  FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for a fluoxetine hydrochloride generic from Lannett Company, Inc.

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

  FDA approved the supplemental application for Fluoxetine from Aurobindo Pharma Limited, indicating continued approval of this generic produc…

• FDA approval · 2014-07-16
  FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for a generic fluoxetine hydrochloride product from Lannett Company, Inc. The approval authorize…

• 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 · 2013-12-16
  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.