← FDA DRUG APPROVALS

FDA ANDA · ANDA090002

NAFCILLIN

nafcillin sodium

Sponsor: ISTITUTO BIO ITA SPA

APPLICATION
ANDA090002
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-30
LATEST ACTION
2018-03-08
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2018-03-08Labeling · Supplement 2 · standardAP
2011-06-30OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →