Obsessive-compulsive Disorder

• 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 · 2013-11-18
  FDA Approved: FLUVOXAMINE MALEATE — Original Application (Actavis Pharma, Inc.)

  FDA approved a generic fluvoxamine maleate product (Actavis Pharma) under Original Application (ANDA). The indication is obsessive-compulsiv…

• 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 · 2013-05-24
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for fluvoxamine maleate.

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• FDA approval · 2013-04-23
  FDA Approved: FLUVOXAMINE MALEATE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma's original application for fluvoxamine maleate, a generic form of fluvoxamine for obsessive-compulsive disorder.

• FDA approval · 2013-03-13
  FDA Approved: FLUVOXAMINE MALEATE — Original Application (Endo USA, Inc.)

  FDA approves the Original Application for fluvoxamine maleate from Endo USA, Inc. as a generic medication.

• 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 · 2013-01-09
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for fluvoxamine maleate submitted by Upsher-Smith Laboratories, LLC.

• FDA approval · 2013-01-03
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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

• 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 · 2012-11-30
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for fluvoxamine maleate filed by ANI Pharmaceuticals, Inc.

• FDA approval · 2012-10-01
  FDA Approved: FLUOXETINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original (ANDA) application for fluoxetine from Heritage Pharmaceuticals (d/b/a Avet), confirming a generic formulation of …

• FDA approval · 2012-09-27
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fluoxetine from Aurobindo Pharma Limited, allowing the generic product to be marketed under the …

• FDA approval · 2012-07-31
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for fluoxetine hydrochloride from PAI Holdings (PAI Pharma), confirming approval of a generic fluoxe…

• 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 · 2012-07-31
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited, authorizing its marketing as a gen…

• FDA approval · 2012-04-19
  FDA Approved: FLUOXETINE — Supplemental Application (TIME CAP LABORATORIES, INC.)

  FDA approved a supplemental application for fluoxetine hydrochloride from Time Cap Laboratories, Inc., updating the regulatory status of thi…

• 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 · 2012-02-28
  FDA Approved: FLUOXETINE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approves a supplemental application for a generic fluoxetine hydrochloride product from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2012-02-28
  FDA Approved: FLUOXETINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves the supplemental application for fluoxetine from Alembic Pharmaceuticals Limited, enabling the generic fluoxetine product to be…

• 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.