APPLICATION
ANDA062981
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-10
LATEST ACTION
2025-10-31
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
PENICILLIN V POTASSIUMDiscontinued
PENICILLIN V POTASSIUM EQ 250MG BASE/5ML · FOR SOLUTION · ORAL
PENICILLIN V POTASSIUMDiscontinued
PENICILLIN V POTASSIUM EQ 125MG BASE/5ML · FOR SOLUTION · ORAL
Approval history
2025-10-31Labeling · Supplement 12 · standardAP
1995-12-15Manufacturing (CMC) · Supplement 5AP
1994-01-06Labeling · Supplement 1AP
1993-12-06Manufacturing (CMC) · Supplement 2AP
1993-12-06Labeling · Supplement 3AP
1989-02-10OriginalAP
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.