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FDA ANDA · ANDA077860

RISPERIDONE

Sponsor: WATSON LABS

APPLICATION
ANDA077860
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-05
LATEST ACTION
2024-08-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RISPERIDONEDiscontinued
RISPERIDONE 4MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 2MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.5MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 3MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 1MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.25MG · TABLET · ORAL

Approval history

2024-08-27Labeling · Supplement 5 · standardAP
2020-11-10Labeling · Supplement 4 · standardAP
2020-11-10Labeling · Supplement 3 · standardAP
2012-02-13Labeling · Supplement 2AP
2011-04-22Labeling · Supplement 1AP
2008-12-05Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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