APPLICATION
ANDA063098
TYPE
ANDA
ORIGINAL APPROVAL
1989-05-04
LATEST ACTION
2001-09-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
ERYTHROMYCINDiscontinued
ERYTHROMYCIN 250MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2001-09-27Labeling · Supplement 13AP
2001-05-21Labeling · Supplement 12AP
1999-12-21Manufacturing (CMC) · Supplement 11AP
1999-05-20Manufacturing (CMC) · Supplement 10AP
1998-12-01Manufacturing (CMC) · Supplement 9AP
1998-11-02Manufacturing (CMC) · Supplement 8AP
1995-05-08Manufacturing (CMC) · Supplement 5AP
1994-12-23Manufacturing (CMC) · Supplement 7AP
1994-10-11Manufacturing (CMC) · Supplement 6AP
1993-08-11Labeling · Supplement 4AP
1992-04-03Manufacturing (CMC) · Supplement 3AP
1992-04-03Manufacturing (CMC) · Supplement 1AP
1989-05-04OriginalAP
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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