APPLICATION
ANDA062223
TYPE
ANDA
ORIGINAL APPROVAL
1979-08-27
LATEST ACTION
2000-12-28
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
TOTACILLINDiscontinued
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL
TOTACILLINDiscontinued
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 125MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2000-12-28Labeling · Supplement 4AP
1991-11-08Labeling · Supplement 3AP
1979-08-27OriginalAP
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.