APPLICATION
ANDA062746
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-22
LATEST ACTION
2022-03-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
ERYTHROMYCINPrescription
ERYTHROMYCIN 250MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2022-03-10Labeling · Supplement 14 · standardAP
2022-03-10Labeling · Supplement 12 · standardAP
2009-09-28Labeling · Supplement 10AP
2009-07-06Labeling · Supplement 9AP
2004-03-17Labeling · Supplement 5AP
1998-04-20Manufacturing (CMC) · Supplement 6AP
1986-12-22OriginalAP
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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