Schizophrenia

• FDA approval · 2011-08-25
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' supplemental application for risperidone, authorizing a generic version of the antipsychotic. The …

• FDA approval · 2011-08-24
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  The FDA approved a supplemental application for risperidone from Janssen Pharmaceuticals, Inc. The approval updates the drug's labeling.

• FDA approval · 2011-08-24
  FDA Approved: RISPERIDONE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA's generic risperidone (ANDA201003).

• FDA approval · 2011-08-16
  FDA Approved: RISPERIDONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Risperidone from Torrent Pharmaceuticals Limited, authorizing changes to the approved generic pr…

• FDA approval · 2011-08-12
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  The FDA granted a supplemental approval for Haloperidol Decanoate submitted by Patriot Pharmaceuticals LLC.

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• FDA approval · 2011-08-09
  FDA Approved: RISPERIDONE — Supplemental Application (Amici Pharma, Inc.)

  The FDA approved Amici Pharma, Inc.'s supplemental application for risperidone, authorizing a generic version of the antipsychotic under an …

• FDA approval · 2011-07-11
  FDA Approved: RISPERIDONE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approves a supplemental application for Risperidone by Zydus Lifesciences Limited, confirming regulatory approval of changes to the prod…

• FDA approval · 2011-07-08
  FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental application for SEROQUEL (quetiapine) submitted by H2-Pharma, LLC.

• FDA approval · 2011-06-30
  FDA Approved: RISPERIDONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  The FDA approves a supplemental application for generic risperidone by Jubilant Cadista Pharmacuticals Inc., enabling the generic product to…

• FDA approval · 2011-06-30
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals, LLC's supplemental application for risperidone (RISPERIDONE). This action approves the generic pro…

• FDA approval · 2011-06-15
  FDA Approved: INVEGA SUSTENNA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INVEGA SUSTENNA (paliperidone palmitate) from Janssen Pharmaceuticals.

• FDA approval · 2011-06-15
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  The FDA approved Janssen Pharmaceutical, Inc.'s supplemental application for risperidone, resulting in updated labeling.

• FDA approval · 2011-06-15
  FDA Approved: RISPERDAL M-TAB — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Risperdal M-TAB (risperidone) filed by Janssen Pharmaceuticals, Inc., resulting in an updated/ex…

• FDA approval · 2011-05-25
  FDA Approved: RISPERIDONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved the original application for risperidone generic manufactured by Amneal Pharmaceuticals LLC.

• FDA approval · 2011-05-18
  FDA Approved: RISPERIDONE — Original Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC's original application for a generic risperidone product (ANDA 077543). The approval enables marketing of the…

• FDA approval · 2011-05-17
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SEROQUEL XR (quetiapine) by AstraZeneca Pharmaceuticals LP to update or expand the labeling.

• FDA approval · 2011-04-19
  FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for risperidone from Aurobindo Pharma Limited, marking clearance to market this generic product.

• FDA approval · 2011-04-11
  FDA Approved: CLOZAPINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Clozapine from Mylan Pharmaceuticals, indicating an updated or expanded use for the Clozapin…

• 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 · 2011-03-21
  FDA Approved: FANAPT — Supplemental Application (Vanda Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Fanapt (iloperidone) from Vanda Pharmaceuticals Inc., resulting in changes to the drug's lab…

• 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 · 2011-03-01
  FDA Approved: HALOPERIDOL DECANOATE — Supplemental Application (Patriot Pharmaceuticals LLC)

  The FDA approved a supplemental application for haloperidol decanoate, a long-acting injectable antipsychotic, from Patriot Pharmaceuticals …

• 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 · 2010-12-06
  FDA Approved: HALOPERIDOL — Supplemental Application (Zydus Lifesciences Limited)

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