← FDA DRUG APPROVALS

FDA ANDA · ANDA078464

RISPERIDONE

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA078464
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-08
LATEST ACTION
2016-01-05
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

RISPERIDONEDiscontinued
RISPERIDONE 3MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 4MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2016-01-05Labeling · Supplement 5 · standardAP
2013-04-08OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →