Premenstrual Dysphoric Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-04-15FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approves Lupin's original (generic) application for fluoxetine hydrochloride.
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FDA approval · 2019-03-20FDA Approved: FLUOXETINE — Original Application (ScieGen Pharmaceuticals, Inc)
FDA approved ScieGen Pharmaceuticals' original application for fluoxetine, authorizing the marketing of a generic fluoxetine product. Fluoxe…
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FDA approval · 2019-01-31FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for sertraline hydrochloride from Rising Pharma Holdings, expanding the availability of a generi…
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FDA approval · 2019-01-25FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (NorthStar Rx LLC)
FDA approved an original generic application for fluoxetine hydrochloride from NorthStar Rx LLC. Fluoxetine hydrochloride is used to treat m…
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FDA approval · 2019-01-10FDA Approved: FLUOXETINE — Original Application (ScieGen Pharmaceuticals, Inc.)
FDA approved ScieGen Pharmaceuticals' original abbreviated new drug application for fluoxetine hydrochloride (generic fluoxetine), authorizi…
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FDA approval · 2018-11-21FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Taro Pharmaceuticals U.S.A., Inc.)
FDA granted approval for the original application of a generic fluoxetine hydrochloride product.
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FDA approval · 2018-05-08FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)
The FDA approves Accord Healthcare, Inc.'s supplemental application for sertraline hydrochloride (sertraline HCl).
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FDA approval · 2017-12-08FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for sertraline hydrochloride submitted by Mylan Pharmaceuticals, likely affecting the product la…
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FDA approval · 2017-11-20FDA Approved: FLUOXETINE — Original Application (NIVAGEN PHARMACEUTICALS, INC.)
FDA approved NIVAGEN Pharmaceuticals' original application for fluoxetine hydrochloride, granting marketing approval for a generic version o…
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FDA approval · 2017-11-16FDA Approved: FLUOXETINE — Original Application (Endo USA, Inc.)
FDA approves Endo USA, Inc.'s original application for a generic fluoxetine product.
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FDA approval · 2017-08-03FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Sertraline Hydrochloride submitted by Rising Pharma Holdings, Inc.
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FDA approval · 2017-06-15FDA Approved: ZOLOFT — Supplemental Application (ROERIG)
FDA approved a supplemental application for ZOLOFT (sertraline hydrochloride) submitted by ROERIG, indicating an approved modification to th…
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FDA approval · 2017-04-28FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)
The FDA has approved a supplemental application for paroxetine filed by Padagis US LLC. This notice indicates FDA approval of an amendment t…
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FDA approval · 2017-04-05FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)
FDA approves Alembic Pharmaceuticals Limited's original application for fluoxetine hydrochloride (fluoxetine) as a generic drug.
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FDA approval · 2017-01-04FDA 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 · 2017-01-04FDA Approved: FLUOXETINE — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for fluoxetine from Dr. Reddy's Laboratories Limited.
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FDA approval · 2017-01-04FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for a generic fluoxetine hydrochloride product manufactured by Lannett Company, Inc.
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FDA approval · 2017-01-04FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)
FDA approves a supplemental application from Aurobindo Pharma Limited to market a generic fluoxetine product.
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FDA approval · 2017-01-04FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)
FDA approved a supplemental application for fluoxetine submitted by Saptalis Pharmaceuticals, LLC.
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FDA approval · 2017-01-04FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
The FDA approved a supplemental application for a generic Fluoxetine hydrochloride product from PAI Holdings dba PAI Pharma under ANDA 07601…
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FDA approval · 2016-12-27FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for fluoxetine hydrochloride from Lannett Company, Inc., resulting in approval of their generic fluo…
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FDA approval · 2016-12-27FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental application for fluoxetine hydrochloride from PAI Holdings, LLC dba PAI Pharma.
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FDA approval · 2016-12-27FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)
FDA granted a supplemental approval for a generic fluoxetine product from Aurobindo Pharma Limited under an ANDA.
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FDA approval · 2016-12-27FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)
The FDA approved a supplemental application for fluoxetine (generic) from Saptalis Pharmaceuticals, LLC, for continued marketing under the a…
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FDA approval · 2016-12-23FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for sertraline hydrochloride (generic) manufactured by Mylan Pharmaceuticals Inc.; this represen…