APPLICATION
ANDA062162
TYPE
ANDA
ORIGINAL APPROVAL
1981-06-15
LATEST ACTION
2000-07-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ERYTHROMYCIN ESTOLATEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 125MG BASE · CAPSULE · ORAL
ERYTHROMYCIN ESTOLATEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 250MG BASE · CAPSULE · ORAL
Approval history
2000-07-27Labeling · Supplement 18AP
1999-12-21Manufacturing (CMC) · Supplement 19AP
1999-05-20Manufacturing (CMC) · Supplement 17AP
1998-12-01Manufacturing (CMC) · Supplement 16AP
1998-07-16Labeling · Supplement 15AP
1994-12-23Manufacturing (CMC) · Supplement 14AP
1994-10-11Manufacturing (CMC) · Supplement 13AP
1993-08-10Labeling · Supplement 12AP
1992-04-03Manufacturing (CMC) · Supplement 11AP
1992-04-03Manufacturing (CMC) · Supplement 9AP
1991-10-28Labeling · Supplement 8AP
1989-03-08Manufacturing (CMC) · Supplement 7AP
1981-06-15OriginalAP
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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