APPLICATION
ANDA061580
TYPE
ANDA
ORIGINAL APPROVAL
1972-01-06
LATEST ACTION
2000-09-25
ROUTE
FOR RX COMPOUNDING
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
BACI-RXDiscontinued
BACITRACIN 5,000,000 UNITS/BOT · POWDER · FOR RX COMPOUNDING
Approval history
2000-09-25Manufacturing (CMC) · Supplement 4AP
1994-07-29Manufacturing (CMC) · Supplement 1AP
1994-06-20Manufacturing (CMC) · Supplement 2AP
1972-01-06OriginalAP
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.