Schizoaffective Disorder

• FDA approval · 2021-02-18
  FDA Approved: CLOZAPINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application from Aurobindo Pharma Limited for clozapine, allowing the generic product to be marketed.

• FDA approval · 2021-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA approves Dr. Reddy's Laboratories' supplemental application to add a generic aripiprazole orally disintegrating tablet.

• FDA approval · 2020-10-30
  FDA Approved: PALIPERIDONE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for paliperidone (generic) submitted by NorthStar RxLLC.

• FDA approval · 2020-07-29
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  FDA approved a supplemental application for Versacloz (clozapine) submitted by TruPharma LLC.

• FDA approval · 2020-07-26
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental ANDA for Clozapine from Mylan Pharmaceuticals, approving a generic version of Clozapine under ANDA 201824.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2019-01-25
  FDA Approved: INVEGA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVEGA (paliperidone) submitted by Janssen Pharmaceuticals, Inc.

• FDA approval · 2019-01-16
  FDA Approved: CLOZAPINE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's supplemental application for clozapine (generic) under ANDA202873.

• FDA approval · 2017-11-17
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Clozapine submitted by Mylan Pharmaceuticals Inc. for the generic product (ANDA201824).

• 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 · 2017-06-30
  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 · 2017-04-25
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Clozapine submitted by Mylan Pharmaceuticals Inc., granting updated marketing authorization for …

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

  The FDA approved a supplemental application for INVEGA (paliperidone) from Janssen Pharmaceuticals, Inc.

• FDA approval · 2017-02-23
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  The FDA approved a supplemental application for Versacloz (clozapine) filed by TruPharma LLC. The action constitutes FDA approval of the sup…

• FDA approval · 2016-11-29
  FDA Approved: CLOZAPINE — Original Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma's generic Clozapine under an original ANDA, authorizing its use as a treatment for schizophrenia (including tr…

• FDA approval · 2016-10-06
  FDA Approved: ZYPREXA INTRAMUSCULAR — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Zyprexa Intramuscular (olanzapine) by Eli Lilly and Company to support the intramuscular for…

• FDA approval · 2016-02-18
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  The FDA approved a supplemental application for Versacloz (clozapine) submitted by TruPharma LLC.

• FDA approval · 2016-01-22
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals' supplemental application for clozapine (generic), enabling a generic version under ANDA201824.

• FDA approval · 2015-11-25
  FDA Approved: CLOZAPINE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's original application for clozapine, granting approval for a generic clozapine product.

• FDA approval · 2015-10-08
  FDA Approved: CLOZARIL — Supplemental Application (HLS Therapeutics (USA), Inc.)

  The FDA has approved a supplemental application for Clozaril (clozapine) filed by HLS Therapeutics (USA), Inc.

• FDA approval · 2015-09-24
  FDA Approved: PALIPERIDONE — Original Application (Archis Pharma LLC)

  FDA approved Archis Pharma LLC's paliperidone original application, authorizing a generic paliperidone product. Paliperidone is used to trea…

• FDA approval · 2013-08-22
  FDA Approved: VERSACLOZ — Supplemental Application (TruPharma LLC)

  The FDA granted approval of a supplemental application for Versacloz (clozapine) submitted by TruPharma LLC.

• FDA approval · 2012-11-27
  FDA Approved: RISPERIDONE — Supplemental Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's generic risperidone through an ANDA, authorizing the generic product for the same indications as the brand.

• FDA approval · 2012-08-29
  FDA Approved: INVEGA SUSTENNA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approves a supplemental application for INVEGA SUSTENNA (paliperidone palmitate) submitted by Janssen Pharmaceuticals, extending/adjusti…

• 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…