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FDA ANDA · ANDA065448

PENICILLIN G POTASSIUM

Sponsor: ISTITUTO BIO ITA SPA

APPLICATION
ANDA065448
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-18
LATEST ACTION
2016-01-30
ROUTE
INTRAVENOUS, INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PENICILLIN G POTASSIUMPrescription
PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL · INJECTABLE · INJECTION
PENICILLIN G POTASSIUMPrescription
PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL · INJECTABLE · INJECTION

Approval history

2016-01-30Labeling · Supplement 5 · standardAP
2012-08-24Labeling · Supplement 3AP
2009-08-18OriginalAP
VIEW ON DRUGS@FDA ↗

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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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