← FDA DRUG APPROVALS

FDA ANDA · ANDA087240

AMINOPHYLLINE

Sponsor: LUITPOLD

APPLICATION
ANDA087240
TYPE
ANDA
ORIGINAL APPROVAL
1981-04-16
LATEST ACTION
1990-06-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AMINOPHYLLINEDiscontinued
AMINOPHYLLINE 25MG/ML · INJECTABLE · INJECTION

Approval history

1990-06-19Labeling · Supplement 8AP
1989-03-07Manufacturing (CMC) · Supplement 6AP
1989-03-07Manufacturing (CMC) · Supplement 7AP
1981-04-16OriginalAP
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 →