← FDA DRUG APPROVALS

FDA ANDA · ANDA090576

NIZATIDINE

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA090576
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-18
LATEST ACTION
2009-11-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

NIZATIDINEDiscontinued
NIZATIDINE 15MG/ML · SOLUTION · ORAL

Approval history

2009-11-18OriginalLetterAP
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 →