← FDA DRUG APPROVALS
FDA NDA · NDA050138
BICILLIN C-R 900/300
penicillin g benzathine and penicillin g procaine
Sponsor: KING PHARMS LLC
APPLICATION
NDA050138
TYPE
NDA
ORIGINAL APPROVAL
1953-05-18
LATEST ACTION
2026-06-25
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
BICILLIN C-R · ReferenceDiscontinued
PENICILLIN G BENZATHINE 150,000 UNITS/ML, PENICILLIN G PROCAINE 150,000 UNITS/ML · INJECTABLE · INJECTION
BICILLIN C-R 900/300 · ReferencePrescription
PENICILLIN G BENZATHINE 900,000 UNITS/2ML, PENICILLIN G PROCAINE 300,000 UNITS/2ML · INJECTABLE · INJECTION
BICILLIN C-R · ReferencePrescription
PENICILLIN G BENZATHINE 300,000 UNITS/ML, PENICILLIN G PROCAINE 300,000 UNITS/ML · INJECTABLE · INJECTION
Approval history
2001-03-23Manufacturing (CMC) · Supplement 221AP
1997-11-25Manufacturing (CMC) · Supplement 220AP
1993-09-22Labeling · Supplement 217 · standardAP
1993-09-09Manufacturing (CMC) · Supplement 13AP
1989-05-31Labeling · Supplement 214AP
1989-05-31Labeling · Supplement 215AP
1989-05-31Labeling · Supplement 213AP
1988-06-16Manufacturing (CMC) · Supplement 212AP
1988-06-16Manufacturing (CMC) · Supplement 12AP
1988-05-16Labeling · Supplement 211AP
1988-04-14Manufacturing (CMC) · Supplement 210AP
1987-11-17Labeling · Supplement 209AP
1987-09-28Labeling · Supplement 208AP
1986-12-08Manufacturing (CMC) · Supplement 206AP
1986-12-05Labeling · Supplement 203AP
1986-12-05Labeling · Supplement 205AP
1985-11-18Manufacturing (CMC) · Supplement 202AP
1983-10-12Labeling · Supplement 201AP
1983-07-28Labeling · Supplement 199AP
1983-07-19Labeling · Supplement 200AP
1982-07-28Labeling · Supplement 198AP
1982-07-16Labeling · Supplement 197AP
1981-12-21Labeling · Supplement 196AP
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.
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