APPLICATION
ANDA062353
TYPE
ANDA
ORIGINAL APPROVAL
1982-11-18
LATEST ACTION
2001-01-18
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
ERYTHROMYCIN ESTOLATEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 125MG BASE/5ML · SUSPENSION · ORAL
Approval history
2001-01-18Labeling · Supplement 26AP
2000-09-11Manufacturing (CMC) · Supplement 25AP
1999-02-11Manufacturing (CMC) · Supplement 24AP
1995-08-18Manufacturing (CMC) · Supplement 22AP
1993-10-22Manufacturing (CMC) · Supplement 21AP
1993-04-07Labeling · Supplement 20AP
1992-04-06Manufacturing (CMC) · Supplement 17AP
1992-01-27Manufacturing (CMC) · Supplement 18AP
1991-10-09Labeling · Supplement 19AP
1991-07-24Manufacturing (CMC) · Supplement 13AP
1991-03-18Manufacturing (CMC) · Supplement 12AP
1990-09-28Manufacturing (CMC) · Supplement 16AP
1989-01-26Manufacturing (CMC) · Supplement 8AP
1982-11-18OriginalAP
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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