APPLICATION
ANDA084476
TYPE
ANDA
ORIGINAL APPROVAL
1976-04-30
LATEST ACTION
1994-02-24
ROUTE
OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
DOMEBORO · ReferenceDiscontinued
ACETIC ACID, GLACIAL 2%, ALUMINUM ACETATE 0.79% · SOLUTION/DROPS · OTIC
Approval history
1994-02-24Labeling · Supplement 10AP
1985-10-29Manufacturing (CMC) · Supplement 7AP
1985-10-29Manufacturing (CMC) · Supplement 6AP
1982-03-19Manufacturing (CMC) · Supplement 5AP
1976-04-30OriginalAP
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.