Premenstrual Dysphoric Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2013-02-01FDA Approved: ZOLOFT — Supplemental Application (ROERIG)
FDA approved a supplemental application for ZOLOFT (sertraline hydrochloride) submitted by ROERIG.
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FDA approval · 2013-01-29FDA 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…
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FDA approval · 2012-12-21FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for sertraline hydrochloride by Quallent Pharmaceuticals Health LLC.
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FDA approval · 2012-10-01FDA 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 …
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FDA approval · 2012-09-27FDA 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 …
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FDA approval · 2012-04-19FDA 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…
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FDA approval · 2012-02-28FDA Approved: FLUOXETINE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)
FDA approves a supplemental application for a generic fluoxetine hydrochloride product from Quallent Pharmaceuticals Health LLC.
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FDA approval · 2012-02-28FDA 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…
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FDA approval · 2011-12-27FDA Approved: PAROXETINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application from Mylan Pharmaceuticals for paroxetine hydrochloride hemihydrate, authorizing a generic version o…
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FDA approval · 2011-11-22FDA 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…
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FDA approval · 2011-08-19FDA 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…
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FDA approval · 2011-07-27FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for paroxetine hydrochloride (paroxetine) from Zydus Lifesciences Limited under an ANDA.
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FDA approval · 2011-03-14FDA 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 · 2011-03-11FDA Approved: YAZ — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for Yaz (drospirenone and ethinyl estradiol) from Bayer HealthCare Pharmaceuticals, indicating a…
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FDA approval · 2011-03-04FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited.
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FDA approval · 2011-01-30FDA 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 …
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FDA approval · 2010-12-10FDA 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…
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FDA approval · 2010-05-19FDA 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…
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FDA approval · 2010-03-25FDA Approved: PAROXETINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for paroxetine hydrochloride hemihydrate from Mylan Pharmaceuticals Inc., advancing the generic …
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FDA approval · 2010-03-25FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for paroxetine hydrochloride from Apotex Corp., granting approval for an additional generic product.
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FDA approval · 2010-03-22FDA 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…
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FDA approval · 2009-09-28FDA 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…
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FDA approval · 2009-09-28FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved the supplemental application for sertraline hydrochloride from Granules Pharmaceuticals Inc., confirming regulatory approval of…
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FDA approval · 2009-09-28FDA 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 …
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FDA approval · 2009-08-31FDA 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…