Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-07-28FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for divalproex sodium submitted by BluePoint Laboratories, associated with an existing ANDA.
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FDA approval · 2023-07-28FDA Approved: LAMOTRIGINE — Supplemental Application (Dr. Reddys Laboratories Inc.)
FDA approved a supplemental application for lamotrigine from Dr. Reddy's Laboratories Inc., under the ANDA process.
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FDA approval · 2023-07-17FDA Approved: ARIPIPRAZOLE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for aripiprazole from Ascend Laboratories, allowing a generic version to be marketed.
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FDA approval · 2023-06-29FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's supplemental application for ARIPIPRAZOLE, granting approval of the generic ARIPIPRAZOLE product.
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FDA approval · 2023-06-15FDA Approved: ARIPIPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for aripiprazole from Quallent Pharmaceuticals Health LLC.
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FDA approval · 2023-06-12FDA Approved: ARIPIPRAZOLE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental application for ARIPIPRAZOLE submitted by Unichem Pharmaceuticals (USA), Inc., enabling the generic product to b…
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FDA approval · 2023-06-09FDA Approved: LURASIDONE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)
FDA approves a generic Lurasidone hydrochloride tablet (ANDA 212124) from Macleods Pharmaceuticals Limited. The product is indicated for sch…
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FDA approval · 2023-06-08FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental application for Lamotrigine from Unichem Pharmaceuticals (USA), Inc.
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FDA approval · 2023-06-07FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approves a supplemental application for olanzapine from Macleods Pharmaceuticals Limited, granting approval of a generic version of the …
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FDA approval · 2023-06-07FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Quetiapine Fumarate by Macleods Pharmaceuticals Limited under ANDA203359.
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FDA approval · 2023-06-07FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for ziprasidone hydrochloride filed by Macleods Pharmaceuticals Limited under an ANDA, indicating a …
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FDA approval · 2023-06-07FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Olanzapine submitted by Macleods Pharmaceuticals Limited (ANDA 203044). This is a regulatory upd…
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FDA approval · 2023-06-07FDA Approved: QUETIAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for a generic quetiapine product from Macleods Pharmaceuticals Limited.
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FDA approval · 2023-06-05FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)
The FDA approved Accord Healthcare Inc.'s supplemental application for quetiapine (ANDA 202152), granting approval of a generic quetiapine p…
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FDA approval · 2023-05-30FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approves a supplemental application for quetiapine fumarate submitted by Unichem Pharmaceuticals (USA), Inc.
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FDA approval · 2023-05-11FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for quetiapine fumarate submitted by BluePoint Laboratories. This action approves a modification to …
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FDA approval · 2023-05-11FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for quetiapine fumarate filed by Sun Pharmaceutical Industries.
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FDA approval · 2023-05-11FDA Approved: QUETIAPINE EXTENDED RELEASE — Supplemental Application (ACI Healthcare USA, Inc.)
FDA approves a supplemental application for a generic Quetiapine Extended Release product from ACI Healthcare USA, expanding access to the e…
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FDA approval · 2023-05-11FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for quetiapine fumarate from Aurobindo Pharma Limited, enabling generic production under an Abbrevia…
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FDA approval · 2023-05-11FDA Approved: QUETIAPINE — Supplemental Application (Ascend Laboratories, LLC)
The FDA granted a supplemental approval for Quetiapine (generic) from Ascend Laboratories, LLC, approving an additional application for this…
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FDA approval · 2023-05-08FDA Approved: LITHIUM CARBONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for lithium carbonate from Glenmark Pharmaceuticals Inc., USA, indicating approval of changes to the…
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FDA approval · 2023-05-01FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)
FDA announces a supplemental approval for a generic fixed-dose combination of olanzapine and fluoxetine by Par Health USA, LLC under ANDA 07…
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FDA approval · 2023-04-28FDA Approved: UZEDY — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved UZEDY (risperidone) through an original application from Teva Pharmaceuticals USA, Inc. for the treatment of schizophrenia, bip…
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FDA approval · 2023-04-20FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
FDA approved a supplemental application for quetiapine fumarate from Ingenus Pharmaceuticals, LLC, marking an additional approval/modificati…
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FDA approval · 2023-04-19FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for quetiapine fumarate from Aurobindo Pharma Limited, authorizing a generic version under an ANDA.