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FDA ANDA · ANDA061910

ILOTYCIN

Sponsor: DISTA

APPLICATION
ANDA061910
TYPE
ANDA
ORIGINAL APPROVAL
1975-02-27
LATEST ACTION
1992-01-31
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

ILOTYCINDiscontinued
ERYTHROMYCIN 250MG · TABLET, DELAYED RELEASE · ORAL

Approval history

1992-01-31Labeling · Supplement 4AP
1991-09-05Labeling · Supplement 5AP
1991-09-05Labeling · Supplement 6AP
1990-04-10Manufacturing (CMC) · Supplement 3AP
1975-02-27OriginalAP
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