Autistic Disorder

• EMA approval · 2026-06-10
  EMA Authorised: Slenyto (melatonin) — RAD Neurim Pharmaceuticals EEC SARL

  Slenyto (melatonin) has been authorized for sleep initiation and maintenance disorders and autistic disorder in the EU.

• FDA approval · 2020-02-06
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' supplemental abbreviated new drug application for aripiprazole, granting approval of a generic version.

• FDA approval · 2020-02-05
  FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for RISPERDAL CONSTA (risperidone) from Janssen Pharmaceuticals, Inc., signaling an approved mod…

• FDA approval · 2020-02-05
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal M-Tab (risperidone) from Janssen Pharmaceuticals.

• FDA approval · 2017-02-23
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for aripiprazole, enabling the generic version to be marketed.

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• FDA approval · 2011-11-28
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for a generic risperidone product from Amneal Pharmaceuticals NY LLC under ANDA 078071.

• FDA approval · 2011-11-04
  FDA Approved: RISPERIDONE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved Jubilant Cadista's generic risperidone under an Original Application (ANDA 090839).

• FDA approval · 2010-12-01
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved Janssen's supplemental application for Risperdal M-TAB (risperidone), a supplemental filing related to the M-TAB formulatio…