Premenstrual Dysphoric Disorder

• FDA approval · 2021-10-04
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Alvogen, Inc.)

  FDA approves the sertraline hydrochloride generic under an Original Application filed by Alvogen, Inc. The approval enables marketing of a g…

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for Fluoxetine Hydrochloride from Lannett Company, Inc., a generic fluoxetine product.

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved a supplemental application for fluoxetine submitted by Chartwell Governmental & Specialty RX, LLC.

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for fluoxetine hydrochloride submitted by PAI Holdings, LLC dba PAI Pharma. The approval updates the…

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (Torrent Pharmaceuticals Limited)

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

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• 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 HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

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

• FDA approval · 2021-09-01
  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…

• 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 · 2021-08-25
  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 · 2021-05-03
  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 · 2021-02-06
  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 · 2020-07-21
  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 · 2020-06-10
  FDA Approved: FLUOXETINE — Original Application (Aurobindo Pharma Limited)

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

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

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

• FDA approval · 2020-04-08
  FDA Approved: FLUOXETINE — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic fluoxetine product from Aurobindo Pharma Limited under an Original Application (ANDA 213286). Fluoxetine is an SSRI i…

• FDA approval · 2020-02-21
  FDA Approved: SERTRALINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for sertraline from Heritage Pharmaceuticals (d/b/a Avet), signaling approval of a change or additio…

• FDA approval · 2020-02-21
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride (generic sertraline).

• FDA approval · 2020-02-21
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for an additional generic version of sertraline hydrochloride, expanding the availability of this an…

• FDA approval · 2019-09-11
  FDA Approved: PAROXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)

  FDA supplemental approval granted for Apotex Corp's paroxetine hydrochloride product, approving a generic formulation under NDA 020936.

• FDA approval · 2019-05-23
  FDA Approved: FLUOXETINE — Original Application (Cadila Pharmaceuticals Limited)

  Cadila Pharmaceuticals Limited received FDA approval for an original application of fluoxetine (generic).