APPLICATION
ANDA060456
TYPE
ANDA
ORIGINAL APPROVAL
1968-07-31
LATEST ACTION
2014-07-16
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription
Products
PENICILLIN-VKPrescription
PENICILLIN V POTASSIUM EQ 250MG BASE/5ML · FOR SOLUTION · ORAL
PENICILLIN-VKPrescription
PENICILLIN V POTASSIUM EQ 125MG BASE/5ML · FOR SOLUTION · ORAL
Approval history
2014-07-16Labeling · Supplement 52 · standardAP
2008-04-30Labeling · Supplement 48AP
2007-05-31Labeling · Supplement 46AP
2001-10-30Manufacturing (CMC) · Supplement 42AP
2001-07-27Manufacturing (CMC) · Supplement 41AP
2001-05-15Manufacturing (CMC) · Supplement 40AP
2000-07-07Manufacturing (CMC) · Supplement 39AP
1997-08-19Manufacturing (CMC) · Supplement 38AP
1996-08-30Manufacturing (CMC) · Supplement 37AP
1996-05-24Manufacturing (CMC) · Supplement 35AP
1996-03-27Manufacturing (CMC) · Supplement 36AP
1995-07-14Manufacturing (CMC) · Supplement 34AP
1994-12-22Manufacturing (CMC) · Supplement 33AP
1994-02-02Labeling · Supplement 32AP
1993-08-25Labeling · Supplement 31AP
1993-02-26Labeling · Supplement 30AP
1988-11-10Manufacturing (CMC) · Supplement 29AP
1968-07-31OriginalAP
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.