← FDA DRUG APPROVALS

FDA ANDA · ANDA078187

RISPERIDONE

Sponsor: SYNTHON PHARMS

APPLICATION
ANDA078187
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-22
LATEST ACTION
2009-10-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2009-10-22OriginalAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →