Bipolar Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-05-19FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie.
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FDA approval · 2020-04-24FDA Approved: CARBAMAZEPINE — Original Application (Rising Pharma Holdings, Inc.)
The FDA approved Rising Pharma's original application for carbamazepine, a generic anticonvulsant used to treat epilepsy, trigeminal neuralg…
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FDA approval · 2020-04-23FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company.
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FDA approval · 2020-04-21FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)
The FDA approved Eli Lilly's supplemental application for ZYPREXA Intramuscular (olanzapine), finalizing approval for the intramuscular form…
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FDA approval · 2020-04-21FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company, related to the orodispersible tab…
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FDA approval · 2020-04-21FDA Approved: VALPROIC ACID — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)
FDA approved a supplemental application for valproic acid (generic) submitted by Chartwell Governmental & Specialty RX, LLC.
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FDA approval · 2020-04-15FDA Approved: CARBAMAZEPINE — Original Application (NIVAGEN PHARMACEUTICALS, INC.)
The FDA approved the original application for a generic carbamazepine product from NIVAGEN PHARMACEUTICALS, INC., marking the approval of th…
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FDA approval · 2020-04-01FDA Approved: LAMOTRIGINE — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approves the original abbreviated new drug application for lamotrigine from Zydus Pharmaceuticals USA Inc., making a generic version ava…
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FDA approval · 2020-03-11FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for ziprasidone hydrochloride under an ANDA. This action supports a generic version of …
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FDA approval · 2020-02-28FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for carbamazepine submitted by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2020-02-28FDA Approved: LITHIUM CARBONATE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for lithium carbonate from Rising Pharma Holdings, Inc., updating its labeling and/or indication…
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FDA approval · 2020-02-28FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for carbamazepine, allowing an additional product authorizat…
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FDA approval · 2020-02-27FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental application for EPITOL (carbamazepine). This approval pertains to a supplemental filing for the product…
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FDA approval · 2020-02-21FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)
The FDA approved a supplemental application for divalproex sodium from Dr. Reddy's Laboratories Ltd, indicating an update to its labeling. T…
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FDA approval · 2020-02-20FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)
The FDA approved a supplemental application for divalproex sodium submitted by Dr. Reddy's Laboratories Ltd. This action denotes an approved…
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FDA approval · 2020-02-20FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr.Reddys Laboratories Inc)
The FDA approved a supplemental application for aripiprazole from Dr. Reddy's Laboratories Inc., supporting regulatory action for the generi…
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FDA approval · 2020-02-14FDA Approved: LITHIUM CARBONATE — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approves a supplemental application for Lithium carbonate from Alembic Pharmaceuticals, authorizing an update to an existing product.
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FDA approval · 2020-02-14FDA Approved: LITHIUM CARBONATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application for lithium carbonate submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. The…
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FDA approval · 2020-02-14FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for lithium carbonate by Hikma Pharmaceuticals USA Inc., likely reflecting a labeling or manufacturi…
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FDA approval · 2020-02-12FDA Approved: LAMOTRIGINE — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for Lamotrigine (generic) from Endo USA, Inc. under ANDA 204158, authorizing its marketing in the Un…
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FDA approval · 2020-02-10FDA Approved: LAMOTRIGINE EXTENDED RELEASE — Supplemental Application (Par Health USA, LLC)
The FDA approved a supplemental application for Lamotrigine Extended Release, authorizing its extended-release formulation from Par Health U…
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FDA approval · 2020-02-07FDA Approved: LAMOTRIGINE EXTENDED-RELEASE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application to approve Lamotrigine Extended-Release from Par Health USA, LLC. The product's labeling covers indi…
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FDA approval · 2020-02-06FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' supplemental abbreviated new drug application for aripiprazole, granting approval of a generic version.
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FDA approval · 2020-02-05FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)
The FDA approved a supplemental application for RISPERDAL CONSTA (risperidone) from Janssen Pharmaceuticals, Inc., signaling an approved mod…
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FDA approval · 2020-02-05FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved a supplemental application for Risperdal M-Tab (risperidone) from Janssen Pharmaceuticals.