← FDA DRUG APPROVALS

FDA ANDA · ANDA090005

NAFCILLIN

Sponsor: ISTITUTO BIO ITA SPA

APPLICATION
ANDA090005
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-20
LATEST ACTION
2020-07-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NAFCILLIN SODIUMPrescription
NAFCILLIN SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2020-07-27Labeling · Supplement 6 · standardAP
2020-07-27Labeling · Supplement 7 · standardAP
2020-07-27Labeling · Supplement 5 · standardAP
2013-01-15Labeling · Supplement 4 · standardAP
2012-09-04Labeling · Supplement 2AP
2011-04-20OriginalAP
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 →