Premenstrual Dysphoric Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-08-18FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)
The FDA approved a supplemental application for fluoxetine hydrochloride from Dr. Reddy's Laboratories Limited. This is an approved amendmen…
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FDA approval · 2023-08-18FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)
The FDA approved a supplemental application for paroxetine submitted by Padagis US LLC. This action represents an additional regulatory appr…
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FDA approval · 2023-08-18FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approved a supplemental application for fluoxetine hydrochloride from Alembic Pharmaceuticals Limited.
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FDA approval · 2023-08-10FDA Approved: FLUOXETINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for fluoxetine from Torrent Pharmaceuticals Limited, enabling the generic antidepressant to be manuf…
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FDA approval · 2023-03-31FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)
FDA approved a supplemental application for Granules Pharmaceuticals' sertraline hydrochloride generic product, enabling its marketing in th…
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FDA approval · 2023-01-31FDA Approved: PAROXETINE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for paroxetine from ANI Pharmaceuticals, indicating an approved change to the product (e.g., lab…
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FDA approval · 2023-01-25FDA Approved: ZOLOFT — Supplemental Application (ROERIG)
The FDA approved a supplemental application for Zoloft (sertraline hydrochloride) filed by Roerig.
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FDA approval · 2022-12-05FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA has approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride, allowing the generic to be marketed as part o…
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CLINICAL_TRIALS trial_result · 2022-11-17Clinical Trial Update: Stress & Premenstrual Symptoms Study [Phase 4]
A Phase 4 clinical trial at Johns Hopkins evaluating stress-related symptoms in Premenstrual Dysphoric Disorder has completed, with results …
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FDA approval · 2022-11-15FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)
The FDA approved Upsher-Smith's fluoxetine hydrochloride as an original generic application, allowing the generic product to be marketed wit…
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FDA approval · 2022-11-09FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approves ANI Pharmaceuticals' original application for fluoxetine hydrochloride, a generic version of fluoxetine.
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FDA approval · 2022-08-30FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride as a generic, confirming approval under the ANDA p…
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FDA label_change · 2022-08-30FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for a sertraline hydrochloride generic from Quallent Pharmaceuticals Health LLC, updating the labeli…
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FDA approval · 2022-03-29FDA Approved: FLUOXETINE — Original Application (Micro Labs Limited)
The FDA approved Micro Labs Limited's original application for a generic fluoxetine product.
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FDA approval · 2022-02-25FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited, applying to the generic product.
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FDA approval · 2022-01-19FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)
The FDA granted a supplemental approval for paroxetine hydrochloride (paroxetine) from NorthStar Rx LLC under an ANDA. This approval confirm…
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FDA approval · 2021-11-02FDA Approved: PAROXETINE — Original Application (Chartwell RX, LLC.)
FDA approved a generic paroxetine product under an original ANDA submitted by Chartwell RX, LLC.
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FDA approval · 2021-10-04FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Alvogen, Inc.)
FDA approves the sertraline hydrochloride generic under an Original Application filed by Alvogen, Inc. The approval enables marketing of a g…
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FDA approval · 2021-09-21FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for Fluoxetine Hydrochloride from Lannett Company, Inc., a generic fluoxetine product.
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FDA approval · 2021-09-21FDA 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 · 2021-09-21FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental application for fluoxetine hydrochloride submitted by PAI Holdings, LLC dba PAI Pharma. The approval updates the…
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FDA approval · 2021-09-21FDA Approved: FLUOXETINE — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for fluoxetine submitted by Torrent Pharmaceuticals Limited.
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FDA label_change · 2021-09-21FDA Approved: FLUOXETINE — Supplemental Application (ScieGen Pharmaceuticals, Inc)
FDA approved a supplemental application for fluoxetine by ScieGen Pharmaceuticals to update the labeling for this generic antidepressant.
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FDA label_change · 2021-09-20FDA Approved: ZOLOFT — Supplemental Application (ROERIG)
FDA approved a supplemental application for Zoloft (sertraline hydrochloride) submitted by Roerig to update the product labeling.
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FDA approval · 2021-09-20FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)
The FDA approved a supplemental application for fluoxetine from Saptalis Pharmaceuticals, LLC., enabling a generic fluoxetine product under …