Premenstrual Dysphoric Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-09-12FDA Approved: ZOLOFT — Supplemental Application (ROERIG)
The FDA approved a supplemental application for Zoloft (sertraline hydrochloride) submitted by Roerig.
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FDA approval · 2014-09-11FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approves a supplemental application for Fluoxetine hydrochloride (fluoxetine) from PAI Holdings, LLC dba PAI Pharma.
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FDA approval · 2014-08-11FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental application for a fluoxetine hydrochloride generic product submitted by PAI Holdings (PAI Pharma).
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FDA approval · 2014-07-18FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a fluoxetine hydrochloride generic from Lannett Company, Inc.
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FDA approval · 2014-07-17FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved the supplemental application for Fluoxetine from Aurobindo Pharma Limited, indicating continued approval of this generic produc…
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FDA approval · 2014-07-16FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for a generic fluoxetine hydrochloride product from Lannett Company, Inc. The approval authorize…
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CLINICAL_TRIALS trial_result · 2014-04-02Clinical Trial Update: YAZ Premenstrual Dysphoric Disorder (PMDD) in China [Phase 3]
A Phase 3 trial evaluating YAZ (drospirenone/ethinyl estradiol) for Premenstrual Dysphoric Disorder in China has completed.
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FDA approval · 2013-12-31FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for a generic paroxetine hydrochloride product manufactured by NorthStar Rx LLC.
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FDA approval · 2013-12-31FDA Approved: PAROXETINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Paroxetine hydrochloride hemihydrate from Mylan Pharmaceuticals, confirming the continued author…
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FDA approval · 2013-12-16FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride (generic sertraline), enabling a new generic versi…
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FDA approval · 2013-09-26FDA Approved: ZOLOFT — Supplemental Application (ROERIG)
FDA approved a supplemental application for ZOLOFT (sertraline hydrochloride) submitted by Roerig.
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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 label_change · 2013-02-01FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA supplemental approval for sertraline hydrochloride from Mylan to update labeling.
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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.