Bipolar Disorder

• FDA approval · 2024-10-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for lamotrigine from Ascend Laboratories, granting approval for a generic lamotrigine product.

• FDA approval · 2024-10-01
  FDA Approved: LAMOTRIGINE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved a generic lamotrigine product from Alembic Pharmaceuticals Limited under an Original Application (ANDA211821).

• FDA approval · 2024-09-24
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Devatis, Inc.)

  The FDA approved Devatis, Inc.'s original application for chlorpromazine hydrochloride, a generic antipsychotic. It covers a generic product…

• FDA approval · 2024-09-09
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for risperidone by Amneal Pharmaceuticals LLC to bring a generic version of the medication to market…

• FDA approval · 2024-08-13
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Northstar Rx LLC)

  FDA approved a supplemental application for carbamazepine from Northstar Rx LLC under ANDA 216594, indicating regulatory approval of changes…

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• FDA approval · 2024-07-14
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for risperidone from Zydus Lifesciences Limited. This action authorizes a supplemental approval …

• FDA approval · 2024-06-26
  FDA Approved: OLANZAPINE — Supplemental Application (American Regent, Inc.)

  FDA approved a supplemental application for olanzapine from American Regent, Inc. for the generic product; the notice indicates a supplement…

• FDA approval · 2024-06-13
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2024-06-05
  FDA Approved: LAMOTRIGINE — Supplemental Application (Yiling Pharmaceutical, Inc.)

  FDA approved Yiling Pharmaceutical's supplemental application to market Lamotrigine Extended-Release, a lamotrigine product.

• FDA approval · 2024-05-29
  FDA Approved: OLANZAPINE — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc.'s supplemental application for olanzapine (ANDA201588). This action updates the approval for the generic product, p…

• FDA approval · 2024-05-28
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved a supplemental application for aripiprazole submitted by Alembic Pharmaceuticals Inc., authorizing a modification to the pr…

• FDA approval · 2024-04-15
  FDA Approved: LAMOTRIGINE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for lamotrigine from Ajanta Pharma USA Inc.

• FDA approval · 2024-04-11
  FDA Approved: LAMOTRIGINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's supplemental application for lamotrigine (ANDA 079099), resulting in an approved change to the lamotrigine product u…

• FDA approval · 2024-04-11
  FDA Approved: HALOPERIDOL — Original Application (Lifestar Pharma LLC)

  FDA approved a generic haloperidol product from Lifestar Pharma LLC under an Original Application (ANDA 216918).

• FDA approval · 2024-03-21
  FDA Approved: PALIPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's supplemental application for Paliperidone, enabling the marketing of a generic paliperidone product. This is an admini…

• FDA approval · 2024-03-18
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2024-03-18
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie's supplemental application for Depakote Sprinkles (divalproex sodium).

• FDA approval · 2024-03-18
  FDA Approved: LITHIUM — Original Application (Saptalis Pharmaceuticals, LLC)

  FDA approved Saptalis Pharmaceuticals' generic lithium product under an original ANDA.

• FDA approval · 2024-03-15
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for aripiprazole submitted by Chartwell RX, LLC, indicating regulatory approval of a supplement rela…

• FDA approval · 2024-03-12
  FDA Approved: OLANZAPINE — Supplemental Application (Aurobindo Pharma Limited)

  This FDA document relates to a supplemental application for the generic antipsychotic olanzapine from Aurobindo Pharma Limited. The action p…

• FDA approval · 2024-03-11
  FDA Approved: QUETIAPINE — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approved a supplemental application for a generic version of quetiapine, enabling Solco Healthcare U.S., LLC to market a generic quetiap…

• EMA approval · 2024-03-08
  EMA Authorised: Zalasta (olanzapine) — Krka

  Krka-licensed olanzapine (Zalasta) has been authorised in the EU for schizophrenia and bipolar disorder.

• FDA approval · 2024-03-05
  FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for risperidone filed by Solco Healthcare US, LLC.

• FDA approval · 2024-03-05
  FDA Approved: RISPERIDONE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for risperidone from Chartwell RX, LLC, authorizing the generic product under the approved label.

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

  FDA approved a supplemental application for carbamazepine submitted by ANI Pharmaceuticals, Inc.