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
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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