Obsessive-compulsive Disorder

• 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.

• 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 · 2017-05-24
  FDA Approved: CLOMIPRAMINE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for clomipramine hydrochloride submitted by SpecGx LLC.

• 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 · 2017-04-05
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's original application for fluoxetine hydrochloride (fluoxetine) as a generic drug.

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• FDA approval · 2017-03-24
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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

• 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: PROZAC — Supplemental Application (Dista Products Company)

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

• FDA approval · 2017-01-04
  FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for fluoxetine from Dr. Reddy's Laboratories Limited.

• FDA approval · 2017-01-04
  FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for a generic fluoxetine hydrochloride product manufactured by Lannett Company, Inc.

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

  FDA approves a supplemental application from Aurobindo Pharma Limited to market a generic fluoxetine product.

• FDA approval · 2017-01-04
  FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)

  FDA approved a supplemental application for fluoxetine submitted by Saptalis Pharmaceuticals, LLC.

• FDA approval · 2017-01-04
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for a generic Fluoxetine hydrochloride product from PAI Holdings dba PAI Pharma under ANDA 07601…

• FDA approval · 2016-12-27
  FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for fluoxetine hydrochloride from Lannett Company, Inc., resulting in approval of their generic fluo…

• FDA approval · 2016-12-27
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for fluoxetine hydrochloride from PAI Holdings, LLC dba PAI Pharma.

• FDA approval · 2016-12-27
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA granted a supplemental approval for a generic fluoxetine product from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2016-12-27
  FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)

  The FDA approved a supplemental application for fluoxetine (generic) from Saptalis Pharmaceuticals, LLC, for continued marketing under the a…

• 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 · 2016-10-21
  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 · 2016-06-10
  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 · 2016-03-14
  FDA Approved: FLUOXETINE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  The FDA approved a supplemental application from Quallent Pharmaceuticals Health LLC to market fluoxetine hydrochloride as a generic product…

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

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