← FDA DRUG APPROVALS

FDA ANDA · ANDA206251

ARIPIPRAZOLE

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA206251
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-07
LATEST ACTION
2016-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2016-12-07UNKNOWN · Original · standardLetterAP
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 →