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FDA ANDA · ANDA090560

NAFCILLIN

nafcillin sodium

Sponsor: ANTIBIOTICE

APPLICATION
ANDA090560
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-03
LATEST ACTION
2022-12-06
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NAFCILLIN SODIUMPrescription
NAFCILLIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
NAFCILLIN SODIUMPrescription
NAFCILLIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2022-12-06Labeling · Supplement 7 · standardAP
2021-01-27Labeling · Supplement 5 · standardAP
2021-01-27Labeling · Supplement 3 · standardAP
2011-10-03OriginalAP
VIEW ON DRUGS@FDA ↗

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