APPLICATION
NDA050440
TYPE
NDA
ORIGINAL APPROVAL
1972-10-12
LATEST ACTION
1991-07-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
KEFLETDiscontinued
CEPHALEXIN EQ 1GM BASE · TABLET · ORAL
KEFLET · ReferenceDiscontinued
CEPHALEXIN EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
KEFLET · ReferenceDiscontinued
CEPHALEXIN EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1991-07-30Labeling · Supplement 19AP
1990-04-10Labeling · Supplement 18AP
1987-01-27Manufacturing (CMC) · Supplement 9AP
1986-07-16Labeling · Supplement 11AP
1985-11-22Labeling · Supplement 8AP
1985-09-06Labeling · Supplement 7AP
1984-09-05Manufacturing (CMC) · Supplement 6AP
1983-09-28Labeling · Supplement 4AP
1983-09-28Labeling · Supplement 5AP
1983-08-15Manufacturing (CMC) · Supplement 3AP
1983-02-15Manufacturing (CMC) · Supplement 2AP
1982-09-17Labeling · Supplement 45AP
1982-09-17Efficacy · Supplement 43AP
1982-09-17Labeling · Supplement 44AP
1982-03-09Manufacturing (CMC) · Supplement 42AP
1981-09-04Labeling · Supplement 41AP
1981-02-11Manufacturing (CMC) · Supplement 40AP
1980-12-31Labeling · Supplement 39AP
1980-05-12Labeling · Supplement 38AP
1980-03-19Manufacturing (CMC) · Supplement 37AP
1980-03-04Manufacturing (CMC) · Supplement 36AP
1979-11-21Labeling · Supplement 35AP
1979-05-21Labeling · Supplement 34AP
1979-04-20Manufacturing (CMC) · Supplement 33AP
1979-01-13Labeling · Supplement 31AP
1978-11-07Efficacy · Supplement 30AP
1978-05-18Manufacturing (CMC) · Supplement 29AP
1977-05-25Manufacturing (CMC) · Supplement 28AP
1977-03-11Manufacturing (CMC) · Supplement 27AP
1977-02-28Labeling · Supplement 26AP
1976-11-08Manufacturing (CMC) · Supplement 24AP
1976-11-02Labeling · Supplement 25AP
1975-11-17Labeling · Supplement 23AP
1975-10-20Manufacturing (CMC) · Supplement 22AP
1975-06-20Labeling · Supplement 21AP
1974-12-27Manufacturing (CMC) · Supplement 20AP
1972-10-12OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.