Bipolar Disorder

• FDA approval · 2010-12-01
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC. The approval covers the supplemental su…

• FDA approval · 2010-12-01
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2010-12-01
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for SEROQUEL XR (quetiapine) submitted by AstraZeneca Pharmaceuticals LP.

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

  The FDA approved Janssen's supplemental application for Risperdal M-TAB (risperidone), a supplemental filing related to the M-TAB formulatio…

• FDA approval · 2010-11-04
  FDA Approved: LAMOTRIGINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for lamotrigine from Jubilant Cadista Pharmaceuticals Inc., indicating approved changes to labeling.

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• FDA approval · 2010-10-24
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approves a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2010-10-24
  FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2010-09-07
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for a generic lithium carbonate product, updating its approval status. The action does not …

• FDA approval · 2010-09-03
  FDA Approved: SAPHRIS — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for SAPHRIS (asenapine maleate) by Allergan, Inc.

• FDA approval · 2010-08-30
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal M-TAB (risperidone) from Janssen Pharmaceuticals, expanding or updating its formulatio…

• FDA approval · 2010-08-06
  FDA Approved: RISPERIDONE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's generic risperidone (ANDA) for the same indications as the brand-label. The approval covers schizophrenia,…

• FDA approval · 2010-08-06
  FDA Approved: RISPERIDONE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries, Inc.'s original ANDA for risperidone, providing a generic version of this antipsychotic.

• FDA approval · 2010-07-28
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit from OWP Pharmaceuticals, Inc., indicating regulatory action on the lamotrigine …

• FDA approval · 2010-07-28
  FDA Approved: LAMOTRIGINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Glenmark's generic lamotrigine product. The approval confirms the generic's labeling and regulat…

• FDA approval · 2010-07-28
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2010-06-29
  FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's supplemental application for risperidone, updating the labeling for this generic product.

• FDA approval · 2010-06-24
  FDA Approved: LITHIUM CARBONATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved the original application for lithium carbonate from Sun Pharmaceutical Industries, expanding access to this generic medicine.

• FDA approval · 2010-06-23
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc., granting approval for changes to the alread…

• FDA approval · 2010-05-28
  FDA Approved: VALPROIC ACID — Original Application (QUAGEN PHARMACEUTICALS LLC)

  The FDA approved a generic version of valproic acid from Quagen Pharmaceuticals LLC under an Original Abbreviated New Drug Application.

• FDA approval · 2010-05-27
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Carbamazepine submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2010-05-27
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA INTRAMUSCULAR (olanzapine) from Eli Lilly and Company.

• FDA approval · 2010-05-27
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for ZYPREXA ZYDIS (olanzapine) submitted by Eli Lilly and Company.

• FDA approval · 2010-04-27
  FDA Approved: RISPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for risperidone from ANI Pharmaceuticals, Inc., under an ANDA.

• FDA approval · 2010-03-15
  FDA Approved: VALPROIC ACID — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved the supplemental application for Valproic Acid filed by PAI Holdings dba PAI Pharma.

• FDA approval · 2010-02-23
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved the Supplemental Application for lamotrigine by Aurobindo Pharma Limited, resulting in approval of a generic lamotrigine produc…