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FDA NDA · NDA050678

DYNABAC

Sponsor: LILLY RES LABS

APPLICATION
NDA050678
TYPE
NDA
ORIGINAL APPROVAL
1995-06-19
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

DYNABACDiscontinued
DIRITHROMYCIN 250MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2007-12-07Labeling · Supplement 7 · standardAP
2007-12-07Labeling · Supplement 2 · standardAP
2002-05-23Labeling · Supplement 10 · standard — Letter ↗AP
2002-04-01Manufacturing (CMC) · Supplement 12 · standardAP
2000-08-01Manufacturing (CMC) · Supplement 11 · standardAP
1998-09-28Manufacturing (CMC) · Supplement 8 · standardAP
1998-07-22Labeling · Supplement 5 · standardAP
1998-07-21Manufacturing (CMC) · Supplement 6 · standardAP
1998-04-13Manufacturing (CMC) · Supplement 4 · standardAP
1997-12-19Efficacy · Supplement 3 · standard — Review ↗AP
1995-06-19Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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