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FDA NDA · NDA050199

UNIPEN

Sponsor: WYETH AYERST

APPLICATION
NDA050199
TYPE
NDA
ORIGINAL APPROVAL
1965-10-11
LATEST ACTION
1991-05-14
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued

Products

UNIPENDiscontinued
NAFCILLIN SODIUM EQ 250MG BASE/5ML · FOR SOLUTION · ORAL

Approval history

1991-05-14Manufacturing (CMC) · Supplement 6AP
1991-04-10Labeling · Supplement 5AP
1987-09-15Labeling · Supplement 4AP
1986-12-05Labeling · Supplement 3AP
1985-08-27Labeling · Supplement 2AP
1982-12-28Labeling · Supplement 1AP
1982-07-28Manufacturing (CMC) · Supplement 26AP
1980-10-22Manufacturing (CMC) · Supplement 25AP
1980-10-03Labeling · Supplement 24AP
1980-10-02Labeling · Supplement 23AP
1980-05-15Manufacturing (CMC) · Supplement 22AP
1978-04-24Manufacturing (CMC) · Supplement 21AP
1978-04-18Manufacturing (CMC) · Supplement 20AP
1977-12-22Labeling · Supplement 19AP
1976-10-15Manufacturing (CMC) · Supplement 18AP
1976-09-07Labeling · Supplement 17AP
1976-07-26Manufacturing (CMC) · Supplement 15AP
1976-07-26Manufacturing (CMC) · Supplement 14AP
1976-05-04Manufacturing (CMC) · Supplement 16AP
1974-04-11Manufacturing (CMC) · Supplement 13AP
1973-01-24Manufacturing (CMC) · Supplement 12AP
1970-05-06Manufacturing (CMC) · Supplement 11AP
1970-05-06Manufacturing (CMC) · Supplement 10AP
1967-10-16Manufacturing (CMC) · Supplement 9AP
1966-08-05Manufacturing (CMC) · Supplement 8AP
1966-03-10Manufacturing (CMC) · Supplement 7AP
1965-10-11OriginalAP
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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