APPLICATION
NDA050141
TYPE
NDA
ORIGINAL APPROVAL
1952-06-27
LATEST ACTION
2026-06-25
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
BICILLIN L-A · ReferenceDiscontinued
PENICILLIN G BENZATHINE 300,000 UNITS/ML · INJECTABLE · INJECTION
BICILLIN L-A · ReferencePrescription
PENICILLIN G BENZATHINE 600,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2001-03-23Manufacturing (CMC) · Supplement 217AP
1998-01-08Manufacturing (CMC) · Supplement 216AP
1993-09-22Labeling · Supplement 213 · standardAP
1993-08-31Manufacturing (CMC) · Supplement 212AP
1989-05-31Labeling · Supplement 13AP
1988-06-16Manufacturing (CMC) · Supplement 11AP
1988-06-16Manufacturing (CMC) · Supplement 38AP
1988-06-16Manufacturing (CMC) · Supplement 14AP
1988-05-16Labeling · Supplement 10AP
1988-05-03Manufacturing (CMC) · Supplement 9AP
1987-11-17Labeling · Supplement 7AP
1987-09-28Labeling · Supplement 8AP
1986-12-08Labeling · Supplement 6AP
1986-12-05Labeling · Supplement 5AP
1985-11-18Labeling · Supplement 4AP
1985-07-29Labeling · Supplement 3AP
1983-07-08Labeling · Supplement 2AP
1983-05-27Labeling · Supplement 1AP
1982-09-16Efficacy · Supplement 210AP
1982-09-16Labeling · Supplement 211AP
1982-07-28Labeling · Supplement 209AP
1981-12-21Labeling · Supplement 206AP
1980-05-15Labeling · Supplement 204AP
1978-07-27Labeling · Supplement 203AP
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.