APPLICATION
NDA050462
TYPE
NDA
ORIGINAL APPROVAL
1973-10-16
LATEST ACTION
1991-04-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
UNIPENDiscontinued
NAFCILLIN SODIUM EQ 500MG BASE · TABLET · ORAL
Approval history
1991-04-10Labeling · Supplement 7 · standardAP
1987-09-28Labeling · Supplement 6 · standardAP
1987-01-20Manufacturing (CMC) · Supplement 5 · standardAP
1986-12-05Labeling · Supplement 4 · standardAP
1986-11-21Manufacturing (CMC) · Supplement 3 · standardAP
1982-12-28Labeling · Supplement 2 · standardAP
1982-12-14Manufacturing (CMC) · Supplement 1 · standardAP
1982-08-03Manufacturing (CMC) · Supplement 21 · standardAP
1980-09-30Labeling · Supplement 19 · standardAP
1978-04-24Manufacturing (CMC) · Supplement 18 · standardAP
1977-12-22Labeling · Supplement 17 · standardAP
1977-06-02Labeling · Supplement 16 · standardAP
1976-11-22Labeling · Supplement 11 · standardAP
1976-04-21Labeling · Supplement 15 · standardAP
1975-08-19Labeling · Supplement 13 · standardAP
1975-03-23Labeling · Supplement 14 · standardAP
1974-04-11Manufacturing (CMC) · Supplement 10 · standardAP
1974-03-08Labeling · Supplement 8 · standardAP
1974-03-08Manufacturing (CMC) · Supplement 9 · standardAP
1973-10-16Type 3 - New Dosage Form · Original · standardAP
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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