APPLICATION
ANDA060657
TYPE
ANDA
ORIGINAL APPROVAL
1968-08-30
LATEST ACTION
2024-06-14
ROUTE
INTRAMUSCULAR, INTRAPLEURAL, INTRATHECAL, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
PFIZERPENPrescription
PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL · INJECTABLE · INJECTION
PFIZERPENDiscontinued
PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PFIZERPENPrescription
PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL · INJECTABLE · INJECTION
Approval history
2024-06-14Labeling · Supplement 37 · standardAP
2018-04-09Labeling · Supplement 28 · standardAP
2016-07-21Labeling · Supplement 24 · standardAP
2015-05-20Labeling · Supplement 19AP
2014-09-26Labeling · Supplement 21AP
2010-05-15Manufacturing (CMC) · Supplement 18AP
2004-09-16Labeling · Supplement 14AP
1994-07-14Manufacturing (CMC) · Supplement 13AP
1994-02-01Manufacturing (CMC) · Supplement 12AP
1991-02-12Manufacturing (CMC) · Supplement 9AP
1989-08-03Manufacturing (CMC) · Supplement 10AP
1968-08-30OriginalAP
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.