Bipolar Disorder

• FDA approval · 2017-09-26
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for quetiapine fumarate from Sun Pharmaceutical Industries, Inc., approving updates to the generic's…

• FDA approval · 2017-09-26
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application to market a generic quetiapine fumarate product from Aurobindo Pharma Limited.

• FDA approval · 2017-09-08
  FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for risperidone, approving a new generic risperidone product.

• FDA approval · 2017-08-11
  FDA Approved: INVEGA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved Janssen's supplemental application for INVEGA (paliperidone), expanding its approved indications.

• FDA approval · 2017-08-04
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for aripiprazole by Quallent Pharmaceuticals Health LLC, bringing a generic version of the antip…

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• FDA approval · 2017-07-03
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for quetiapine fumarate filed by Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2017-06-30
  FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for quetiapine from Accord Healthcare Inc. (ANDA 202152).

• FDA approval · 2017-06-30
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for quetiapine fumarate (Quetiapine) by BluePoint Laboratories under an existing ANDA. This represen…

• FDA approval · 2017-06-30
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for a generic quetiapine fumarate by Alembic Pharmaceuticals Limited.

• FDA approval · 2017-06-30
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Macleods Pharmaceuticals Limited to market quetiapine fumarate. The approval covers a generic ve…

• FDA approval · 2017-06-22
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for quetiapine fumarate by Hikma Pharmaceuticals USA Inc., representing a new or updated approval fo…

• FDA approval · 2017-06-16
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit from OWP Pharmaceuticals, Inc., enabling its marketing as a lamotrigine-based pr…

• FDA approval · 2017-06-05
  FDA Approved: LITHIUM CARBONATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s original application for lithium carbonate, confirming the generic product's availability for th…

• FDA approval · 2017-05-17
  FDA Approved: QUETIAPINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' generic quetiapine (quetiapine) for the treatment of schizophrenia and bipolar disorder, expanding acces…

• FDA approval · 2017-05-09
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's generic quetiapine fumarate under Original Application (ANDA090681) to bring a quetiapine fumarate product …

• FDA approval · 2017-04-25
  FDA Approved: LAMOTRIGINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for Lamotrigine from Torrent Pharmaceuticals Limited (ANDA203370). The action updates the produc…

• FDA approval · 2017-04-18
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Lamotrigine by Aurobindo Pharma Limited, enabling a new generic version of lamotrigine.

• FDA approval · 2017-03-29
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for aripiprazole, enabling the marketing of a generic aripiprazole product.

• FDA approval · 2017-03-06
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approves a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, authorizing changes to the product labeling …

• FDA approval · 2017-02-23
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for ZYPREXA INTRAMUSCULAR (olanzapine) from Eli Lilly and Company, adding the intramuscular formulat…

• FDA approval · 2017-02-23
  FDA Approved: ZYPREXA ZYDIS — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2017-02-23
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  FDA approved a supplemental application for Risperidone submitted by Janssen Pharmaceutical, Inc. The action pertains to an addition or modi…

• FDA approval · 2017-02-23
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Geodon (ziprasidone) submitted by Viatris Specialty LLC. This action relates to an approved supp…

• FDA approval · 2017-02-23
  FDA Approved: GEODON — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2017-02-23
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SEROQUEL XR (quetiapine) from AstraZeneca Pharmaceuticals LP, updating or expanding its labeling…