Autism Spectrum Disorder

• FDA label_change · 2022-12-02
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved Janssen's supplemental application for Risperdal M-TAB (risperidone), updating labeling and introducing the M-TAB dosage form.

• FDA label_change · 2019-01-25
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA supplemental application for Risperdal M-TAB (risperidone) by Janssen Pharmaceuticals, involving changes to the product label. This acti…

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

  The FDA approved a supplemental application for Risperdal (risperidone) from Janssen Pharmaceuticals, resulting in changes to the product la…

• FDA label_change · 2011-08-24
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA page documents a supplemental application for RISPERDAL M-TAB (risperidone) by Janssen Pharmaceuticals, typically filed to support l…

• FDA label_change · 2011-06-08
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  FDA records a supplemental application for risperidone by Zydus Lifesciences Limited; specifics of the label changes are not provided in the…

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• FDA label_change · 2010-12-01
  FDA Approved: ABILIFY — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  The FDA approved a supplemental application for ABILIFY (aripiprazole) submitted by Otsuka America Pharmaceutical, Inc., resulting in change…