APPLICATION
ANDA060711
TYPE
ANDA
ORIGINAL APPROVAL
1968-07-03
LATEST ACTION
2014-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PENICILLIN-VKPrescription
PENICILLIN V POTASSIUM EQ 500MG BASE · TABLET · ORAL
PENICILLIN-VKPrescription
PENICILLIN V POTASSIUM EQ 250MG BASE · TABLET · ORAL
Approval history
2014-07-16Labeling · Supplement 39 · standardAP
2008-04-30Labeling · Supplement 38AP
2007-09-25Labeling · Supplement 37AP
2001-11-13Manufacturing (CMC) · Supplement 28AP
2001-08-14Manufacturing (CMC) · Supplement 27AP
2001-05-15Manufacturing (CMC) · Supplement 26AP
2000-07-07Manufacturing (CMC) · Supplement 25AP
1996-08-28Manufacturing (CMC) · Supplement 24AP
1996-05-24Manufacturing (CMC) · Supplement 23AP
1995-09-21Manufacturing (CMC) · Supplement 22AP
1994-02-02Labeling · Supplement 21AP
1993-08-25Labeling · Supplement 20AP
1993-08-25Labeling · Supplement 19AP
1993-03-09Labeling · Supplement 16AP
1993-03-09Manufacturing (CMC) · Supplement 17AP
1993-02-26Labeling · Supplement 18AP
1988-11-10Manufacturing (CMC) · Supplement 15AP
1968-07-03OriginalAP
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.