Bipolar Disorder

• FDA approval · 2011-06-15
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal M-TAB (risperidone) filed by Janssen Pharmaceuticals, Inc., resulting in an updated/ex…

• FDA approval · 2011-05-31
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2011-05-25
  FDA Approved: RISPERIDONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved the original application for risperidone generic manufactured by Amneal Pharmaceuticals LLC.

• FDA approval · 2011-05-20
  FDA Approved: CARBAMAZEPINE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approves ANI Pharmaceuticals' original application to market a generic carbamazepine formulation under an ANDA.

• FDA approval · 2011-05-18
  FDA Approved: RISPERIDONE — Original Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC's original application for a generic risperidone product (ANDA 077543). The approval enables marketing of the…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2011-05-17
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SEROQUEL XR (quetiapine) by AstraZeneca Pharmaceuticals LP to update or expand the labeling.

• FDA approval · 2011-04-25
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal XR (lamotrigine) by GlaxoSmithKline LLC.

• FDA approval · 2011-04-19
  FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited, marking clearance to market this generic product.

• FDA approval · 2011-04-05
  FDA Approved: DIVALPROEX SODIUM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the generic divalproex sodium from Unichem Pharmaceuticals (USA), Inc. under ANDA079163.

• FDA approval · 2011-03-30
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Lamotrigine from Aurobindo Pharma Limited. This approval confirms the availability of the lamotr…

• FDA approval · 2011-03-30
  FDA Approved: RISPERIDONE — Original Application (Natco Pharma USA LLC)

  FDA approved Natco Pharma USA LLC's original ANDA for risperidone, enabling a generic version of the antipsychotic. The approval allows Natc…

• FDA approval · 2011-03-16
  FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for risperidone from Jubilant Cadista Pharmaceuticals Inc., confirming continued approval of the gen…

• FDA approval · 2011-03-03
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) from Novartis Pharmaceuticals Corporation, authorizing changes to the p…

• FDA approval · 2011-03-02
  FDA Approved: ABILIFY — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental NDA for ABILIFY (aripiprazole) submitted by Otsuka America Pharmaceutical, Inc., to modify the product labeling …

• FDA approval · 2011-02-14
  FDA Approved: LITHIUM CARBONATE ER — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's original ANDA for extended-release lithium carbonate (lithium carbonate ER), a generic form of the mood stabilizer.

• FDA approval · 2011-01-25
  FDA Approved: VALPROIC ACID — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Valproic acid submitted by Bionpharma Inc.

• FDA approval · 2011-01-21
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for divalproex sodium submitted by NorthStar Rx LLC.

• FDA approval · 2011-01-13
  FDA Approved: LAMOTRIGINE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's generic lamotrigine under an Original Application for marketing in the United States. This ap…

• FDA approval · 2011-01-12
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Lamotrigine from Dr. Reddy's Laboratories Limited, advancing the approval status of its generic …

• FDA approval · 2011-01-11
  FDA Approved: RISPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for risperidone filed by ANI Pharmaceuticals, Inc., indicating an update related to the product’…

• FDA approval · 2010-12-27
  FDA Approved: LITHIUM CARBONATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's lithium carbonate as an original generic application, enabling a generic version of lithium carbonate to be marketed…

• FDA approval · 2010-12-06
  FDA Approved: HALOPERIDOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for haloperidol submitted by Zydus Lifesciences Limited.

• FDA approval · 2010-12-03
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, LLC.

• FDA approval · 2010-12-03
  FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for chlorpromazine hydrochloride from Upsher-Smith Laboratories, indicating an updated regulatory ac…

• FDA approval · 2010-12-01
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for risperidone (RISPERDAL) from Janssen Pharmaceuticals, Inc., resulting in changes to its labe…