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FDA ANDA · ANDA090582

NAFCILLIN SODIUM

Sponsor: SAGENT PHARMS

APPLICATION
ANDA090582
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-24
LATEST ACTION
2021-02-11
ROUTE
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

2021-02-11Labeling · Supplement 1 · standardAP
2021-02-11Labeling · Supplement 5 · standardAP
2021-02-11Labeling · Supplement 3 · standardAP
2012-08-24OriginalAP
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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