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FDA NDA · NDA050111

UNIPEN

Sponsor: WYETH AYERST

APPLICATION
NDA050111
TYPE
NDA
ORIGINAL APPROVAL
1970-04-07
LATEST ACTION
1996-07-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

UNIPENDiscontinued
NAFCILLIN SODIUM EQ 250MG BASE · CAPSULE · ORAL

Approval history

1996-07-30Manufacturing (CMC) · Supplement 28AP
1991-04-10Labeling · Supplement 6AP
1987-09-28Labeling · Supplement 26AP
1987-01-20Manufacturing (CMC) · Supplement 25AP
1986-12-05Manufacturing (CMC) · Supplement 24AP
1985-09-05Efficacy · Supplement 23AP
1982-12-28Labeling · Supplement 22AP
1980-10-02Manufacturing (CMC) · Supplement 21AP
1978-04-24Manufacturing (CMC) · Supplement 20AP
1977-12-22Labeling · Supplement 19AP
1977-02-11Labeling · Supplement 18AP
1976-01-27Labeling · Supplement 17AP
1975-10-03Manufacturing (CMC) · Supplement 16AP
1975-08-19Labeling · Supplement 15AP
1974-06-24Labeling · Supplement 14AP
1974-05-13Labeling · Supplement 13AP
1974-03-27Manufacturing (CMC) · Supplement 12AP
1974-03-12Labeling · Supplement 11AP
1974-03-08Manufacturing (CMC) · Supplement 10AP
1974-02-22Manufacturing (CMC) · Supplement 9AP
1974-01-23Labeling · Supplement 8AP
1973-08-14Labeling · Supplement 7AP
1973-07-24Labeling · Supplement 5AP
1972-08-01Manufacturing (CMC) · Supplement 4AP
1971-10-28Labeling · Supplement 3AP
1971-10-22Labeling · Supplement 2AP
1971-04-22Labeling · Supplement 1AP
1970-04-07OriginalAP
VIEW ON DRUGS@FDA ↗

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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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