Bipolar Disorder

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application to permit Chartwell RX, LLC to market a generic carbamazepine product under an ANDA.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for carbamazepine from Zydus Pharmaceuticals (USA) Inc., updating the approved generic product.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for carbamazepine by Rising Pharma Holdings, Inc.

• FDA approval · 2024-01-16
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for a combined olanzapine and fluoxetine product, submitted by Par Health USA, LLC (brand name Symby…

• FDA approval · 2024-01-09
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for carbamazepine by Upsher-Smith Laboratories, with changes to its approved labeling and indication…

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• FDA approval · 2023-12-27
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for divalproex sodium from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2023-12-22
  FDA Approved: CARBAMAZEPINE — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for Carbamazepine from NIVAGEN Pharmaceuticals, authorizing changes to the generic product under the…

• FDA approval · 2023-12-11
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for carbamazepine filed by Unichem Pharmaceuticals (USA), Inc., signaling an approved change to …

• FDA approval · 2023-12-05
  FDA Approved: RISPERIDONE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva Pharmaceuticals' generic risperidone as an original application (ANDA214068).

• FDA approval · 2023-11-22
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Bionpharma Inc. under an ANDA.

• FDA approval · 2023-11-01
  FDA Approved: UZEDY — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for UZEDY (risperidone) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2023-11-01
  FDA Approved: ARIPIPRAZOLE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic oral aripiprazole under an original ANDA.

• FDA approval · 2023-10-24
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for ziprasidone hydrochloride from BluePoint Laboratories, granting ANDA-based approval of a gen…

• FDA approval · 2023-10-23
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for divalproex sodium from Mylan Pharmaceuticals, indicating regulatory authorization for a generic …

• FDA approval · 2023-10-06
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for divalproex sodium from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2023-10-06
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for divalproex sodium from Upsher-Smith Laboratories, LLC.

• FDA approval · 2023-09-26
  FDA Approved: DIVALPROEX SODIUM — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original ANDA for divalproex sodium, providing a generic option for this anticonvulsant/mood stabilizer…

• FDA approval · 2023-09-25
  FDA Approved: LYBALVI — Supplemental Application (Alkermes, Inc.)

  FDA approved a supplemental application for LYBALVI (olanzapine and samidorphan L-malate) from Alkermes. The action pertains to changes to t…

• FDA approval · 2023-09-19
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Accord Healthcare Inc.)

  FDA approves Accord Healthcare's supplemental application to market quetiapine fumarate as a generic drug.

• FDA approval · 2023-09-18
  FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for risperidone by Jubilant Cadista Pharmaceuticals Inc., updating/expanding its approval for risper…

• FDA approval · 2023-09-13
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-08-14
  FDA Approved: LITHIUM — Original Application (Advagen Pharma Ltd)

  FDA approves Advagen Pharma Ltd's generic lithium carbonate product under an Original Application (ANDA 218036).

• FDA approval · 2023-08-08
  FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited, authorizing a generic risperidone product under ANDA …

• FDA approval · 2023-08-08
  FDA Approved: ZIPRASIDONE MESYLATE — Supplemental Application (Fosun Pharma USA Inc.)

  FDA approved a supplemental application for ziprasidone mesylate, a salt form of ziprasidone, submitted by Fosun Pharma USA Inc.

• FDA approval · 2023-07-31
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for divalproex sodium by Lupin Pharmaceuticals, Inc. under ANDA 078790.