APPLICATION
NDA050010
TYPE
NDA
ORIGINAL APPROVAL
1967-04-13
LATEST ACTION
1998-10-16
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
ILOSONEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 125MG BASE/5ML · SUSPENSION · ORAL
ILOSONEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 250MG BASE/5ML · SUSPENSION · ORAL
Approval history
1998-10-16Manufacturing (CMC) · Supplement 24AP
1997-04-24Labeling · Supplement 22AP
1994-04-18Manufacturing (CMC) · Supplement 18AP
1993-10-28Labeling · Supplement 19AP
1992-08-10Labeling · Supplement 16AP
1992-04-03Labeling · Supplement 12AP
1991-08-22Manufacturing (CMC) · Supplement 14AP
1991-01-07Labeling · Supplement 8AP
1990-12-10Labeling · Supplement 6AP
1990-12-10Labeling · Supplement 7AP
1990-04-16Labeling · Supplement 9AP
1990-04-10Manufacturing (CMC) · Supplement 3AP
1967-04-13OriginalAP
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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