Obsessive-compulsive Disorder

• FDA approval · 2021-09-20
  FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)

  The FDA approved a supplemental application for fluoxetine from Saptalis Pharmaceuticals, LLC., enabling a generic fluoxetine product under …

• FDA approval · 2021-09-20
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fluoxetine from Aurobindo Pharma Limited, granting approval of a generic fluoxetine product.

• FDA approval · 2021-09-20
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for fluoxetine hydrochloride, enabling marketing of a generic fluoxetine produc…

• FDA approval · 2021-09-03
  FDA Approved: PAROXETINE — Original Application (ANI Pharmaceuticals, Inc.)

  ANI Pharmaceuticals received FDA approval for an original ANDA application for paroxetine, a generic antidepressant.

• FDA approval · 2021-09-01
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for fluoxetine hydrochloride from Dr. Reddy's Laboratories Limited (ANDA 078572), updating regulator…

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• FDA approval · 2021-08-31
  FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)

  FDA approved a supplemental application for fluoxetine from Saptalis Pharmaceuticals, confirming the availability of a generic fluoxetine pr…

• FDA approval · 2021-08-27
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for a fluoxetine hydrochloride generic product from PAI Holdings (PAI Pharma). This action approves …

• FDA approval · 2021-08-27
  FDA Approved: PAROXETINE — Original Application (Modavar Pharmaceuticals LLC)

  FDA approved a generic paroxetine tablet product from Modavar Pharmaceuticals LLC under an original abbreviated new drug application (ANDA 2…

• FDA approval · 2021-08-25
  FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

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

• FDA approval · 2021-08-23
  FDA Approved: CLOMIPRAMINE HYDROCHLORIDE — Supplemental Application (Northstar Rx LLC.)

  FDA approved a supplemental application for clomipramine hydrochloride from Northstar Rx LLC., enabling the generic product's continued regu…

• FDA approval · 2021-08-04
  FDA Approved: CLOMIPRAMINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals' generic clomipramine hydrochloride through an original ANDA.

• FDA approval · 2021-05-03
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved the original application for sertraline hydrochloride generic by XLCare Pharmaceuticals, enabling a generic version to be marke…

• FDA approval · 2021-04-19
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc., updating the generic's labeling under the AN…

• FDA approval · 2021-02-16
  FDA Approved: PAROXETINE — Original Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals' generic paroxetine (PAROXETINE) via an Original Application (ANDA213485). It covers indication…

• FDA approval · 2021-02-06
  FDA Approved: PAXIL — Supplemental Application (Apotex Corp)

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

• FDA approval · 2021-01-21
  FDA Approved: FLUOXETINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for fluoxetine submitted by Alembic Pharmaceuticals Limited.

• FDA approval · 2020-12-23
  FDA Approved: FLUOXETINE — Supplemental Application (Cadila Pharmaceuticals Limited)

  FDA approved a supplemental application for Fluoxetine from Cadila Pharmaceuticals Limited, enabling the marketing of this generic fluoxetin…

• FDA approval · 2020-12-17
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for fluvoxamine maleate from Apotex Corp, resulting in approval of a generic version.

• FDA approval · 2020-11-13
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for fluvoxamine maleate from Actavis Pharma, Inc. under an ANDA.

• FDA approval · 2020-08-07
  FDA Approved: CLOMIPRAMINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for clomipramine hydrochloride (generic) from Rising Pharma Holdings, Inc., enabling a generic product…

• FDA approval · 2020-07-21
  FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Paroxetine hydrochloride from Apotex Corp., enabling continued marketing of a generic product.

• FDA approval · 2020-06-22
  FDA Approved: CLOMIPRAMINE HYDROCHLORIDE — Original Application (Micro Labs Limited)

  FDA approves a generic version of clomipramine hydrochloride as an original application by Micro Labs Limited for obsessive-compulsive disor…

• FDA approval · 2020-06-10
  FDA Approved: FLUOXETINE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's generic fluoxetine through an Original Application (ANDA).

• FDA approval · 2020-05-11
  FDA Approved: FLUVOXAMINE MALEATE — Original Application (Bionpharma Inc.)

  FDA approved Bionpharma's original application for fluvoxamine maleate, an SSRI indicated for obsessive-compulsive disorder.

• FDA approval · 2020-04-28
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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