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FDA ANDA · ANDA060272

E-MYCIN

Sponsor: ARBOR PHARMS INC

APPLICATION
ANDA060272
TYPE
ANDA
ORIGINAL APPROVAL
1981-06-23
LATEST ACTION
1999-05-06
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

E-MYCINDiscontinued
ERYTHROMYCIN 250MG · TABLET, DELAYED RELEASE · ORAL
E-MYCINDiscontinued
ERYTHROMYCIN 333MG · TABLET, DELAYED RELEASE · ORAL

Approval history

1999-05-06Labeling · Supplement 34AP
1994-09-01Manufacturing (CMC) · Supplement 30AP
1994-09-01Labeling · Supplement 35AP
1993-11-03Manufacturing (CMC) · Supplement 37AP
1991-12-18Labeling · Supplement 10AP
1990-11-19Manufacturing (CMC) · Supplement 29AP
1989-03-01Manufacturing (CMC) · Supplement 28AP
1981-06-23OriginalAP
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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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