Bipolar Disorder

• FDA approval · 2022-03-31
  FDA Approved: CARBAMAZEPINE ER — Original Application (Bostal LLC)

  FDA approved Bostal LLC's original-application generic extended-release carbamazepine (CARBAMAZEPINE ER), marking the first approval of this…

• FDA approval · 2022-01-28
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC.

• FDA approval · 2022-01-13
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for lurasidone hydrochloride submitted by Accord Healthcare, Inc.

• FDA approval · 2021-12-08
  FDA Approved: LAMOTRIGINE — Original Application (Yiling Pharmaceutical, Inc.)

  The FDA approved Yiling Pharmaceutical's generic lamotrigine extended-release via Original Application (ANDA), enabling a generic lamotrigin…

• FDA approval · 2021-12-01
  FDA Approved: CARBATROL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for CARBATROL (carbamazepine) from Takeda Pharmaceuticals America, Inc.

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• FDA approval · 2021-11-29
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Chartwell RX, LLC)

  FDA approved chlorpromazine hydrochloride from Chartwell RX, LLC under an original ANDA for generic use.

• FDA approval · 2021-11-24
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for a generic olanzapine and fluoxetine fixed-dose combination product. This approval corre…

• FDA approval · 2021-11-24
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for the olanzapine and fluoxetine combination product, expanding the regulatory status for …

• FDA approval · 2021-11-19
  FDA Approved: OLANZAPINE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for Olanzapine from Macleods Pharmaceuticals Limited.

• FDA approval · 2021-11-18
  FDA Approved: OLANZAPINE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for a generic olanzapine product from Upsher-Smith Laboratories, LLC (ANDA204319).

• FDA approval · 2021-11-12
  FDA Approved: QUETIAPINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for a generic quetiapine product (ANDA204203). This marks a supplemental ap…

• FDA approval · 2021-11-09
  FDA Approved: LAMOTRIGINE EXTENDED RELEASE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Lamotrigine Extended Release from Par Health USA, LLC, approving a generic extended-release …

• FDA approval · 2021-11-09
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for quetiapine fumarate from Macleods Pharmaceuticals Limited, enabling a generic version of the…

• FDA approval · 2021-11-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for lamotrigine (NorthStar Rx LLC) under an ANDA.

• FDA approval · 2021-11-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Lamotrigine from Torrent Pharmaceuticals Limited, authorizing a modification to the approved gen…

• FDA approval · 2021-11-03
  FDA Approved: OLANZAPINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for olanzapine from Aurobindo Pharma Limited under ANDA 203708, finalizing approval of a generic…

• FDA approval · 2021-11-02
  FDA Approved: ZIPRASIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approves a supplemental application for ZIPRASIDONE from Dr. Reddy's Laboratories Limited, indicating the approval of a generic version …

• FDA approval · 2021-11-02
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Quetiapine Fumarate from Unichem Pharmaceuticals (USA), Inc. The action approves changes to the …

• FDA approval · 2021-11-01
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic quetiapine fumarate product from Aurobindo Pharma Limited, enabling its use as a g…

• FDA approval · 2021-10-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Advagen Pharma Limited)

  The FDA approved Advagen Pharma Limited's supplemental application for lamotrigine, confirming approval of the requested changes to this gen…

• FDA approval · 2021-10-25
  FDA Approved: LURASIDONE HYDROCHLORIDE — Supplemental Application (Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approves a supplemental application for lurasidone hydrochloride by Heritage Pharma Labs (Avet) under an ANDA, enabling continued or exp…

• FDA approval · 2021-08-31
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for risperidone by Amneal Pharmaceuticals LLC. This action represents a supplemental approval under …

• FDA approval · 2021-07-19
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for ziprasidone hydrochloride from Apotex Corp., enabling the marketing of a generic version of the …

• FDA approval · 2021-07-19
  FDA Approved: QUETIAPINE EXTENDED-RELEASE — Supplemental Application (AlignScience Pharma Inc.)

  FDA approved AlignScience Pharma Inc.'s supplemental application for quetiapine extended-release, enabling its marketing as a generic produc…

• FDA approval · 2021-06-02
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Sandoz, Inc.)

  FDA approved chlorpromazine hydrochloride as a generic drug through an original ANDA submitted by Sandoz, Inc.