APPLICATION
ANDA062758
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-15
LATEST ACTION
1996-02-07
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Discontinued
Products
ERYZOLEDiscontinued
ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML, SULFISOXAZOLE ACETYL EQ 600MG BASE/5ML · GRANULE · ORAL
Approval history
1996-02-07Manufacturing (CMC) · Supplement 8AP
1991-10-28Manufacturing (CMC) · Supplement 7AP
1989-03-03Manufacturing (CMC) · Supplement 2AP
1988-11-03Manufacturing (CMC) · Supplement 1AP
1988-06-15OriginalAP
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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