APPLICATION
ANDA065068
TYPE
ANDA
ORIGINAL APPROVAL
2001-02-26
LATEST ACTION
2020-06-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PENICILLIN G SODIUMPrescription
PENICILLIN G SODIUM 5,000,000 UNITS/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
Approval history
2020-06-22Labeling · Supplement 22 · standardAP
2015-08-18Labeling · Supplement 14AP
2004-09-30Labeling · Supplement 7AP
2002-09-20Labeling · Supplement 4AP
2001-12-06Manufacturing (CMC) · Supplement 1AP
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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