APPLICATION
ANDA062169
TYPE
ANDA
ORIGINAL APPROVAL
1990-10-17
LATEST ACTION
2000-07-27
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
ERYTHROMYCIN ESTOLATEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 125MG BASE/5ML · SUSPENSION · ORAL
ERYTHROMYCIN ESTOLATEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 250MG BASE/5ML · SUSPENSION · ORAL
Approval history
2000-07-27Labeling · Supplement 10AP
1998-12-01Manufacturing (CMC) · Supplement 9AP
1995-02-24Manufacturing (CMC) · Supplement 2AP
1995-02-24Labeling · Supplement 3AP
1994-12-23Manufacturing (CMC) · Supplement 8AP
1993-08-10Labeling · Supplement 7AP
1992-04-03Manufacturing (CMC) · Supplement 6AP
1992-04-03Manufacturing (CMC) · Supplement 4AP
1990-11-14Labeling · Supplement 1AP
1990-10-17OriginalAP
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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