APPLICATION
ANDA062732
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-23
LATEST ACTION
2020-08-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NAFCILLIN SODIUMDiscontinued
NAFCILLIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
NAFCILLIN SODIUMDiscontinued
NAFCILLIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2020-08-07Labeling · Supplement 19 · standardAP
2020-08-07Labeling · Supplement 16 · standardAP
2016-01-03Labeling · Supplement 12AP
2016-01-03Labeling · Supplement 15 · standardAP
2013-10-29Labeling · Supplement 13AP
2004-09-13Labeling · Supplement 6AP
1996-03-26Manufacturing (CMC) · Supplement 3AP
1992-10-30Manufacturing (CMC) · Supplement 2AP
1990-07-24Manufacturing (CMC) · Supplement 1AP
1986-12-23OriginalAP
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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