Autism Spectrum Disorder

• 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 · 2015-10-22
  FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for Risperidone from Jubilant Cadista Pharmaceuticals Inc., signifying an approval related to this g…

• FDA approval · 2015-09-30
  FDA Approved: ARIPIPRAZOLE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s Original Application for aripiprazole, granting approval of a generic version of the antipsychotic.

• FDA approval · 2015-08-27
  FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved a supplemental application for risperidone from Ajanta Pharma USA Inc., indicating an approved regulatory action for this p…

• FDA approval · 2015-04-28
  FDA Approved: ARIPIPRAZOLE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic's original ANDA for aripiprazole, a generic version of the antipsychotic.

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• FDA approval · 2015-04-28
  FDA Approved: ARIPIPRAZOLE — Original Application (Exelan Pharmaceuticals, Inc.)

  FDA approved a generic aripiprazole tablet under ANDA205064 for Exelan Pharmaceuticals, authorizing sale for the same indications as the bra…

• FDA approval · 2015-04-23
  FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2015-03-17
  FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for risperidone by Ajanta Pharma USA Inc., expanding its regulatory clearance for additional indicat…

• FDA approval · 2015-01-12
  FDA Approved: RISPERIDONE — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's generic risperidone through an original ANDA submission, marking the first approval of this generic product…

• FDA approval · 2014-11-28
  FDA Approved: RISPERIDONE — Supplemental Application (Natco Pharma USA LLC)

  The FDA approved a supplemental application for risperidone from Natco Pharma USA LLC under an ANDA, enabling continued marketing of a gener…

• FDA approval · 2014-09-25
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for risperidone from Zydus Lifesciences Limited.

• FDA approval · 2014-09-25
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved a supplemental application for risperidone by Westminster Pharmaceuticals, LLC to support a generic version of risperidone.

• FDA approval · 2014-04-28
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal (risperidone) from Janssen Pharmaceuticals, Inc. The approval updates the drug's label…

• FDA approval · 2013-08-30
  FDA Approved: RISPERIDONE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for risperidone submitted by Par Health USA, LLC (ANDA 077494).

• FDA approval · 2013-07-30
  FDA Approved: ABILIFY — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for Abilify (aripiprazole) by Otsuka America Pharmaceutical, Inc. The action results in updated labe…

• FDA approval · 2013-06-13
  FDA Approved: RISPERDAL — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for RISPERDAL (risperidone) from Janssen Pharmaceuticals, Inc.

• FDA approval · 2012-12-31
  FDA Approved: RISPERIDONE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for risperidone from Ajanta Pharma USA Inc., enabling a new generic risperidone product.

• FDA approval · 2012-12-20
  FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)

  FDA approves a supplemental application for risperidone from Amici Pharma, Inc.

• FDA approval · 2012-12-19
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application from Amneal Pharmaceuticals LLC for risperidone (generic), marking an update to its approval und…

• FDA approval · 2012-12-12
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

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

• FDA approval · 2012-10-29
  FDA Approved: RISPERIDONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for risperidone by Sun Pharmaceutical Industries, Inc. (ANDA 078474).

• FDA approval · 2012-10-22
  FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited (generic risperidone).

• FDA approval · 2012-10-18
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' supplemental application for risperidone under an ANDA, confirming approval of a change associated…

• FDA approval · 2012-08-02
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The U.S. FDA approved a supplemental application for Risperdal M-TAB (risperidone) submitted by Janssen Pharmaceuticals, Inc.

• FDA approval · 2012-07-27
  FDA Approved: RISPERIDONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for risperidone from Sun Pharmaceutical Industries under ANDA078474.