APPLICATION
ANDA087045
TYPE
ANDA
ORIGINAL APPROVAL
1980-09-30
LATEST ACTION
1990-10-31
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
SOMOPHYLLIN-DFDiscontinued
AMINOPHYLLINE 105MG/5ML · SOLUTION · ORAL
Approval history
1990-10-31Labeling · Supplement 15AP
1989-07-20Labeling · Supplement 13AP
1980-09-30OriginalAP
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.