Premenstrual Dysphoric Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2009-08-21FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for generic fluoxetine from Dr. Reddy's Laboratories Limited.
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FDA approval · 2009-08-07FDA Approved: PAXIL — Supplemental Application (Apotex Corp)
FDA approved a supplemental application from Apotex Corp for Paxil (paroxetine hydrochloride).
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FDA approval · 2009-04-21FDA 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…
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FDA approval · 2009-03-19FDA Approved: FLUOXETINE — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for Fluoxetine by Aurobindo Pharma Limited, enabling a generic Fluoxetine product. The approved indica…
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FDA approval · 2009-02-25FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for sertraline hydrochloride from Aurobindo Pharma Limited, a generic version of the antidepressant …
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FDA approval · 2009-01-30FDA Approved: ZOLOFT — Supplemental Application (ROERIG)
FDA approved a supplemental application for Zoloft (sertraline hydrochloride) submitted by ROERIG.
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FDA approval · 2009-01-30FDA Approved: PAROXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for PAROXETINE HYDROCHLORIDE from Apotex Corp.
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FDA approval · 2008-10-31FDA Approved: PAROXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)
FDA approved Apotex Corp's supplemental application for paroxetine hydrochloride (paroxetine HCl), confirming continued approval for the gen…
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FDA approval · 2008-10-31FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)
The FDA approved an original generic application for sertraline hydrochloride by Rising Pharma Holdings, Inc., allowing a generic version of…
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FDA approval · 2008-08-18FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)
FDA approved a supplemental application for fluoxetine submitted by Chartwell Governmental & Specialty RX, LLC.
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FDA approval · 2008-07-16FDA Approved: SERTRALINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approves a supplemental abbreviated new drug application (ANDA) for sertraline from Heritage Pharmaceuticals d/b/a Avet Pharmaceuticals …
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FDA approval · 2008-07-02FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for sertraline hydrochloride (generic sertraline), authorizing the a…
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FDA approval · 2008-06-25FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for sertraline hydrochloride manufactured by Aurobindo Pharma Limited.
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FDA approval · 2008-05-29FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic fluoxetine hydrochloride product from Lannett Company, Inc. under anANDA, confirming r…
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FDA approval · 2008-05-20FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for paroxetine hydrochloride/paroxetine from Zydus Lifesciences Limited, authorizing a generic parox…
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FDA approval · 2008-04-17FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for fluoxetine by Teva Pharmaceuticals USA, Inc. The approval updates the product labeling and/o…
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FDA approval · 2008-03-21FDA Approved: PROZAC — Supplemental Application (Dista Products Company)
FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company.
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FDA approval · 2008-03-13FDA Approved: PAROXETINE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved a generic paroxetine product (paroxetine hydrochloride hemihydrate) from Mylan Pharmaceuticals Inc. under an original ANDA.
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FDA approval · 2008-03-06FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for sertraline hydrochloride from Mylan Pharmaceuticals Inc., indicating approval of a supplemen…
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FDA approval · 2008-02-14FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)
FDA approved a supplemental application for fluoxetine from Chartwell Governmental & Specialty RX, LLC.
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FDA approval · 2008-02-05FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for Apotex Corp. to market a generic paroxetine hydrochloride product (PAROXETINE HYDROCHLORIDE).
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FDA approval · 2008-01-31FDA Approved: FLUOXETINE — Original Application (QUALLENT PHARMACEUTICALS HEALTH LLC)
FDA approved the original application for a generic fluoxetine hydrochloride product from Quallent Pharmaceuticals Health LLC.
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FDA approval · 2008-01-11FDA Approved: SERTRALINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application for a sertraline generic product from Heritage Pharmaceuticals (Avet), authorizing changes to the ap…
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FDA approval · 2008-01-08FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Granules Pharmaceuticals Inc.)
FDA approved Granules Pharmaceuticals Inc.'s sertraline hydrochloride generic under an Original Application. The approval provides a generic…
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FDA approval · 2007-12-26FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for SERTRALINE HYDROCHLORIDE (generic) from Aurobindo Pharma Limited, updating the regulatory status…