Bipolar Disorder

• FDA approval · 2016-09-29
  FDA Approved: ARIPIPRAZOLE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approves Dr. Reddy's Laboratories' generic aripiprazole under an original ANDA application. This action provides a generic option for th…

• FDA approval · 2016-09-23
  FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for EQUETRO (carbamazepine) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2016-09-19
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited.

• FDA approval · 2016-09-12
  FDA Approved: ARIPIPRAZOLE — Original Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved the original ANDA for a generic aripiprazole from Quallent Pharmaceuticals Health LLC. The approval covers a generic versio…

• FDA approval · 2016-09-02
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for lamotrigine from Alembic Pharmaceuticals Limited under an ANDA. This action represents a minor r…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2016-08-29
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, LLC. This action confirms approval …

• FDA approval · 2016-08-18
  FDA Approved: ABILIFY MAINTENA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approves a supplemental application for ABILIFY MAINTENA (aripiprazole) from Otsuka America Pharmaceutical, Inc.

• FDA approval · 2016-08-18
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for aripiprazole from Apotex Corp., authorizing a generic version of the drug. This action represent…

• FDA approval · 2016-07-08
  FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) submitted by Sumitomo Pharma America, Inc.

• FDA approval · 2016-06-17
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SEROQUEL XR (quetiapine) from AstraZeneca Pharmaceuticals LP. This action modifies the product l…

• FDA approval · 2016-06-17
  FDA Approved: LAMOTRIGINE — Original Application (Dr. Reddys Laboratories Inc.)

  The FDA approved the original application for a generic Lamotrigine product from Dr. Reddys Laboratories Inc.

• FDA approval · 2016-05-27
  FDA Approved: LITHOBID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lithobid (lithium carbonate) submitted by ANI Pharmaceuticals, Inc. The approval updates labelin…

• FDA approval · 2016-05-17
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for a generic version of quetiapine fumarate by Macleods Pharmaceuticals Limited.

• FDA approval · 2016-05-12
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2016-05-06
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Lithium Carbonate submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2016-03-08
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Quetiapine Fumarate as a generic tablet under Original Application (ANDA 202674) for Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2016-03-01
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  FDA approved a supplemental application for risperidone submitted by Janssen Pharmaceutical, Inc.

• FDA approval · 2016-03-01
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Risperdal M-Tab (risperidone) from Janssen Pharmaceuticals.

• FDA approval · 2016-03-01
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal (risperidone) by Janssen Pharmaceuticals, Inc.

• FDA approval · 2016-02-26
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Lithium Carbonate submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2016-02-18
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote ER (divalproex sodium) from AbbVie Inc., granting an additional regulatory authorizatio…

• FDA approval · 2016-01-27
  FDA Approved: OLANZAPINE — Original Application (Upsher-Smith Laboratories, LLC)

  Approval of a generic olanzapine product under an Original Application (ANDA) by Upsher-Smith Laboratories, LLC.

• FDA approval · 2016-01-04
  FDA 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.

• FDA approval · 2016-01-04
  FDA Approved: QUETIAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for a generic quetiapine product from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2015-12-26
  FDA Approved: VALPROIC ACID — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for valproic acid from Upsher-Smith Laboratories, LLC.