APPLICATION
ANDA087209
TYPE
ANDA
ORIGINAL APPROVAL
1982-02-01
LATEST ACTION
1995-09-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMINOPHYLLINEDiscontinued
AMINOPHYLLINE 25MG/ML · INJECTABLE · INJECTION
Approval history
1995-09-19Manufacturing (CMC) · Supplement 12AP
1994-06-17Manufacturing (CMC) · Supplement 11AP
1991-03-26Labeling · Supplement 6AP
1987-05-01Manufacturing (CMC) · Supplement 4AP
1986-12-04Manufacturing (CMC) · Supplement 3AP
1982-02-01OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.