APPLICATION
NDA050011
TYPE
NDA
ORIGINAL APPROVAL
1968-05-09
LATEST ACTION
1991-04-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PATHOCIL · ReferenceDiscontinued
DICLOXACILLIN SODIUM EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
PATHOCIL · ReferenceDiscontinued
DICLOXACILLIN SODIUM EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
1991-04-10Manufacturing (CMC) · Supplement 4AP
1987-01-16Manufacturing (CMC) · Supplement 3AP
1985-08-12Efficacy · Supplement 2AP
1983-03-28Manufacturing (CMC) · Supplement 1AP
1983-02-28Manufacturing (CMC) · Supplement 29AP
1982-10-28Manufacturing (CMC) · Supplement 28AP
1982-04-26Manufacturing (CMC) · Supplement 27AP
1981-10-23Manufacturing (CMC) · Supplement 26AP
1980-10-14Manufacturing (CMC) · Supplement 25AP
1980-10-02Labeling · Supplement 24AP
1980-09-19Labeling · Supplement 23AP
1978-04-24Manufacturing (CMC) · Supplement 22AP
1977-01-11Labeling · Supplement 21AP
1976-01-27Labeling · Supplement 20AP
1975-08-15Labeling · Supplement 19AP
1975-05-30Labeling · Supplement 18AP
1974-04-11Labeling · Supplement 17AP
1974-04-01Labeling · Supplement 16AP
1974-03-20Labeling · Supplement 15AP
1974-02-22Labeling · Supplement 14AP
1974-02-22Manufacturing (CMC) · Supplement 13AP
1973-10-05Labeling · Supplement 12AP
1973-03-02Labeling · Supplement 11AP
1972-08-01Labeling · Supplement 10AP
1970-12-14Manufacturing (CMC) · Supplement 9AP
1970-09-01Labeling · Supplement 8AP
1969-09-26Labeling · Supplement 7AP
1968-07-01Labeling · Supplement 6AP
1968-06-05Manufacturing (CMC) · Supplement 5AP
1968-05-09OriginalAP
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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