APPLICATION
ANDA062117
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-27
LATEST ACTION
2000-05-01
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
CEPHALEXINDiscontinued
CEPHALEXIN EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · FOR SUSPENSION · ORAL
CEPHALEXINDiscontinued
CEPHALEXIN EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · FOR SUSPENSION · ORAL
CEPHALEXINDiscontinued
CEPHALEXIN EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · FOR SUSPENSION · ORAL
Approval history
2000-05-01Manufacturing (CMC) · Supplement 34AP
1999-06-01Manufacturing (CMC) · Supplement 33AP
1996-09-19Manufacturing (CMC) · Supplement 32AP
1996-08-06Labeling · Supplement 31AP
1996-07-12Labeling · Supplement 28AP
1995-03-01Labeling · Supplement 30AP
1994-06-23Manufacturing (CMC) · Supplement 29AP
1993-10-25Manufacturing (CMC) · Supplement 26AP
1993-10-01Labeling · Supplement 27AP
1993-06-30Manufacturing (CMC) · Supplement 25AP
1993-01-21Manufacturing (CMC) · Supplement 24AP
1992-11-24Labeling · Supplement 21AP
1992-02-07Labeling · Supplement 20AP
1989-02-28Manufacturing (CMC) · Supplement 19AP
1978-03-27OriginalAP
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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