← FDA DRUG APPROVALS

FDA ANDA · ANDA076228

RISPERIDONE

Sponsor: HERITAGE PHARMA AVET

APPLICATION
ANDA076228
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-30
LATEST ACTION
2026-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RISPERIDONEDiscontinued
RISPERIDONE 0.5MG · TABLET · ORAL
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

Approval history

2026-05-07Labeling · Supplement 21 · standardAP
2026-05-07Labeling · Supplement 20 · standardAP
2020-11-04Labeling · Supplement 17 · standardAP
2020-11-04Labeling · Supplement 18 · standardAP
2020-11-04Labeling · Supplement 19 · standardAP
2012-02-28Labeling · Supplement 16AP
2011-11-10Labeling · Supplement 15AP
2011-06-20Labeling · Supplement 13AP
2011-03-15Labeling · Supplement 12AP
2010-12-29Labeling · Supplement 11AP
2010-05-26Labeling · Supplement 10AP
2010-02-26Labeling · Supplement 8AP
2009-01-23Labeling · Supplement 2AP
2008-11-19Labeling · Supplement 1AP
2008-06-30Original — 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.

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 →