APPLICATION
ANDA062527
TYPE
ANDA
ORIGINAL APPROVAL
1984-08-02
LATEST ACTION
2020-07-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NAFCILLIN SODIUMDiscontinued
NAFCILLIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
NAFCILLIN SODIUMDiscontinued
NAFCILLIN SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
NAFCILLIN SODIUMDiscontinued
NAFCILLIN SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
NAFCILLIN SODIUMDiscontinued
NAFCILLIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2020-07-27Labeling · Supplement 31 · standardAP
2016-01-04Labeling · Supplement 27 · standardAP
2016-01-04Labeling · Supplement 25AP
2016-01-04Labeling · Supplement 28 · standardAP
2016-01-04Manufacturing (CMC) · Supplement 26AP
2016-01-04Labeling · Supplement 24AP
2004-09-30Labeling · Supplement 17AP
1998-08-26Labeling · Supplement 13AP
1984-08-02OriginalAP
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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