Premenstrual Dysphoric Disorder
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2024-09-23Clinical Trial Update: Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder [Phase 2]
Phase 2 clinical trial evaluating combined oral contraceptives for treatment of Premenstrual Dysphoric Disorder in individuals with Bipolar …
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FDA approval · 2024-09-13FDA Approved: FLUOXETINE HCL — Original Application (Strides Pharma Science Limited)
FDA approved a generic fluoxetine hydrochloride product from Strides Pharma Science Limited via an original ANDA. The approval confirms the …
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FDA approval · 2024-08-29FDA Approved: PAROXETINE — Supplemental Application (Modavar Pharmaceuticals LLC)
The FDA approved a supplemental application for paroxetine from Modavar Pharmaceuticals LLC.
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FDA approval · 2024-08-29FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)
FDA approved the supplemental application for Fluoxetine Hydrochloride from Taro Pharmaceuticals U.S.A., Inc. (ANDA211477), enabling the mar…
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FDA label_change · 2024-06-12FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for PAROXETINE HYDROCHLORIDE submitted by Zydus Lifesciences Limited, resulting in changes to the pr…
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CLINICAL_TRIALS trial_result · 2024-05-08Clinical Trial Update: The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms [NA]
A completed clinical trial evaluating the effects of Mixhers HERTIME supplements on menstrual symptoms in healthy participants and those wit…
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FDA approval · 2024-05-02FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for the generic fluoxetine from Aurobindo Pharma Limited (ANDA213265).
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FDA approval · 2024-04-05FDA Approved: FLUOXETINE — Original Application (Strides Pharma Science Limited)
FDA approved an Original Application for a generic Fluoxetine from Strides Pharma Science Limited, enabling a generic version of fluoxetine …
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FDA approval · 2024-02-02FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for sertraline hydrochloride from Rising Pharma Holdings, Inc., resulting in approval of a gener…
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FDA approval · 2024-01-19FDA Approved: PAROXETINE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for Paroxetine by ANI Pharmaceuticals, Inc., indicating approval of a generic product under ANDA 215…
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FDA approval · 2024-01-09FDA Approved: FLUOXETINE — Supplemental Application (Vensun Pharmaceuticals, Inc.)
FDA approved a supplemental application for fluoxetine hydrochloride from Vensun Pharmaceuticals, Inc., granting approval of a generic fluox…
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FDA approval · 2023-11-20FDA Approved: FLUOXETINE — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for fluoxetine submitted by Endo USA, Inc., resulting in regulatory changes to the product's sta…
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FDA approval · 2023-09-22FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for sertraline hydrochloride from Granules Pharmaceuticals Inc. The action confirms continued approv…
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FDA approval · 2023-09-19FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for fluoxetine submitted by Aurobindo Pharma Limited. This action updates the regulatory status …
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FDA approval · 2023-08-21FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
The FDA approved a supplemental application for fluoxetine hydrochloride (generic fluoxetine) submitted by PAI Holdings, dba PAI Pharma.
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FDA approval · 2023-08-21FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for fluoxetine hydrochloride (ANI Pharmaceuticals, Inc.), indicating approval of changes to an alrea…
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FDA approval · 2023-08-18FDA 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 · 2023-08-18FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for sertraline hydrochloride (generic) manufactured by Mylan Pharmaceuticals Inc.
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FDA approval · 2023-08-18FDA 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 · 2023-08-18FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a generic fluoxetine hydrochloride product from Lannett Company, Inc.
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FDA label_change · 2023-08-18FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)
FDA approved a supplemental application for Fluoxetine to update the labeling. The applicant is Chartwell Governmental & Specialty RX, LLC.
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FDA approval · 2023-08-18FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for fluoxetine hydrochloride from Endo USA, Inc.
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FDA approval · 2023-08-18FDA Approved: FLUOXETINE — Supplemental Application (ScieGen Pharmaceuticals, Inc)
FDA approved a supplemental application for a ScieGen Pharmaceuticals generic fluoxetine product under anANDA process.
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FDA approval · 2023-08-18FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Alvogen, Inc.)
FDA approved a supplemental application for sertraline hydrochloride (Alvogen), resulting in labeling changes to the approved NDA.
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FDA approval · 2023-08-18FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for fluoxetine hydrochloride submitted by Upsher-Smith Laboratories, LLC.