Obsessive-compulsive Disorder

• FDA approval · 2011-11-22
  FDA Approved: FLUOXETINE — Supplemental Application (TIME CAP LABORATORIES, INC.)

  FDA approved a supplemental application for fluoxetine hydrochloride from Time Cap Laboratories, Inc., enabling the generic product Fluoxeti…

• FDA approval · 2011-08-19
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for SERTRALINE HYDROCHLORIDE (Mylan Pharmaceuticals Inc.), indicating regulatory action on this gene…

• FDA approval · 2011-07-27
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride (paroxetine) from Zydus Lifesciences Limited under an ANDA.

• FDA approval · 2011-03-16
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for fluvoxamine maleate by ANI Pharmaceuticals, indicating changes to the existing approval (e.g., l…

• FDA approval · 2011-03-14
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for sertraline hydrochloride from Aurobindo Pharma Limited, enabling its generic product.

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• FDA approval · 2011-03-04
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited.

• FDA approval · 2011-01-30
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Paroxetine hydrochloride by Zydus Lifesciences Limited, indicating an update to the labeling or …

• FDA approval · 2010-12-10
  FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for paroxetine hydrochloride (paroxetine) submitted by NorthStar Rx LLC. This action represents an a…

• FDA approval · 2010-10-15
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride (generic) from Zydus Lifesciences Limited, authorizing a generic paroxe…

• FDA approval · 2010-06-25
  FDA Approved: FLUOXETINE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for fluoxetine hydrochloride (fluoxetine) from QUALLENT PHARMACEUTICALS HEALTH LLC, updating the app…

• FDA approval · 2010-06-21
  FDA Approved: PAROXETINE HYDROCHLORIDE — Original Application (Oxford Pharmaceuticals, LLC)

  FDA approved Paroxetine hydrochloride as an Original Application (ANDA) generic for Oxford Pharmaceuticals, LLC.

• FDA approval · 2010-05-19
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (Apotex Corp)

  FDA approves a supplemental application for fluvoxamine maleate from Apotex Corp. This action updates the approval status of the generic pro…

• FDA approval · 2010-05-19
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for fluoxetine submitted by Teva Pharmaceuticals USA, Inc. (the snippet does not specify the exact c…

• FDA approval · 2010-03-25
  FDA Approved: PAROXETINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for paroxetine hydrochloride hemihydrate from Mylan Pharmaceuticals Inc., advancing the generic …

• FDA approval · 2010-03-25
  FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for paroxetine hydrochloride from Apotex Corp., granting approval for an additional generic product.

• FDA approval · 2010-03-22
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved a generic version of fluoxetine hydrochloride (an SSRI) from Dr. Reddy's Laboratories Limited under an Original Application (AN…

• FDA approval · 2009-09-28
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc., updating the approval status of the drug. Th…

• FDA approval · 2009-09-28
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved the supplemental application for sertraline hydrochloride from Granules Pharmaceuticals Inc., confirming regulatory approval of…

• FDA approval · 2009-09-28
  FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved a supplemental application for fluoxetine (generic) filed by Chartwell Governmental & Specialty RX, LLC. The approval confirms …

• FDA approval · 2009-08-31
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for sertraline hydrochloride from Quallent Pharmaceuticals Health LLC, enabling the generic prod…

• FDA approval · 2009-08-21
  FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

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

• FDA approval · 2009-08-07
  FDA Approved: PAXIL — Supplemental Application (Apotex Corp)

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

• FDA approval · 2009-04-21
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved a supplemental application for sertraline hydrochloride from Granules Pharmaceuticals Inc., indicating approval of a modificati…

• FDA approval · 2009-04-15
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for fluvoxamine maleate filed by Chartwell RX, LLC.

• FDA approval · 2009-03-19
  FDA Approved: FLUOXETINE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original ANDA for fluoxetine from Alembic Pharmaceuticals Limited, enabling a generic version of fluoxetine to be marketed.