Autism Spectrum Disorder

• 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 · 2011-03-02
  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 · 2011-01-11
  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 · 2010-12-01
  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…

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• 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 · 2010-06-29
  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 · 2010-04-27
  FDA Approved: RISPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)

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

• FDA approval · 2010-02-19
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals, LLC's supplemental application for risperidone (ANDA 078707). This action represents an approval r…

• FDA approval · 2010-01-12
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for risperidone filed by Zydus Lifesciences Limited, granting approval for a generic version und…

• FDA approval · 2009-12-15
  FDA Approved: RISPERIDONE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for risperidone from ANI Pharmaceuticals, Inc., resulting in a generic risperidone product being…

• FDA approval · 2009-12-02
  FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves a supplemental application for a generic risperidone version manufactured by Torrent Pharmaceuticals Limited.

• FDA approval · 2009-09-04
  FDA Approved: RISPERIDONE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for risperidone, a generic antipsychotic, authorizing its manufacturing and mar…

• FDA approval · 2009-08-24
  FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)

  FDA approved a supplemental application for risperidone by Amici Pharma, Inc., signaling a labeling update or additional indication for the …

• FDA approval · 2009-07-19
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal M-TAB (risperidone) from Janssen Pharmaceuticals. The notice lists the submission stat…

• FDA approval · 2009-06-17
  FDA Approved: RISPERIDONE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's original ANDA for risperidone, authorizing a generic version of the antipsychotic.

• FDA approval · 2009-04-30
  FDA Approved: RISPERIDONE — Original Application (Par Health USA, LLC)

  FDA approves Par Health USA, LLC's original application for a generic risperidone product, expanding access to the standard indications for …

• FDA approval · 2009-03-23
  FDA Approved: RISPERIDONE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved the original application for Risperidone from Jubilant Cadista Pharmaceuticals Inc., enabling generic risperidone to be markete…

• FDA approval · 2009-02-24
  FDA Approved: RISPERIDONE — Original Application (Amici Pharma, Inc.)

  FDA approves the original application for a risperidone generic from Amici Pharma, Inc.

• FDA approval · 2009-01-30
  FDA Approved: RISPERIDONE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approves ANI Pharmaceuticals' original application for risperidone, adding a generic version of the antipsychotic.

• FDA approval · 2008-10-30
  FDA Approved: RISPERIDONE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's original application for risperidone, providing a generic version of the antipsychotic.

• FDA approval · 2008-10-16
  FDA Approved: RISPERIDONE — Original Application (Zydus Lifesciences Limited)

  FDA approved an original abbreviated new drug application for risperidone by Zydus Lifesciences Limited, enabling the sale of a generic risp…

• FDA approval · 2008-08-14
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  FDA approved a supplemental application for risperidone from Janssen Pharmaceuticals, updating the drug's labeling.