← FDA DRUG APPROVALS

FDA ANDA · ANDA090472

ARIPIPRAZOLE

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA090472
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-07
LATEST ACTION
2023-08-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ARIPIPRAZOLEDiscontinued
ARIPIPRAZOLE 20MG · TABLET · ORAL
ARIPIPRAZOLEDiscontinued
ARIPIPRAZOLE 10MG · TABLET · ORAL
ARIPIPRAZOLEDiscontinued
ARIPIPRAZOLE 2MG · TABLET · ORAL
ARIPIPRAZOLEDiscontinued
ARIPIPRAZOLE 30MG · TABLET · ORAL
ARIPIPRAZOLEDiscontinued
ARIPIPRAZOLE 15MG · TABLET · ORAL
ARIPIPRAZOLEDiscontinued
ARIPIPRAZOLE 5MG · TABLET · ORAL

Approval history

2023-08-07Labeling · Supplement 2 · standardAP
2023-08-07Labeling · Supplement 3 · standardAP
2023-08-07Labeling · Supplement 1 · standardAP
2019-01-07OriginalAP
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 →