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FDA NDA · NDA050521

CECLOR

Sponsor: LILLY

APPLICATION
NDA050521
TYPE
NDA
ORIGINAL APPROVAL
1979-04-04
LATEST ACTION
2004-03-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CECLOR · ReferenceDiscontinued
CEFACLOR EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
CECLOR · ReferenceDiscontinued
CEFACLOR EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2004-03-17Labeling · Supplement 27 · standard — Label ↗AP
2003-03-03Labeling · Supplement 26 · standard — Letter ↗AP
2000-04-27Manufacturing (CMC) · Supplement 25 · standardAP
2000-03-13Manufacturing (CMC) · Supplement 24 · standardAP
1999-07-29Manufacturing (CMC) · Supplement 23 · standardAP
1998-09-18Labeling · Supplement 22 · standardAP
1998-02-02Labeling · Supplement 21 · standard — Review ↗AP
1996-09-30Labeling · Supplement 18 · standardAP
1996-05-01Labeling · Supplement 10 · standardAP
1996-05-01Labeling · Supplement 11 · standardAP
1996-03-06Labeling · Supplement 17 · standardAP
1995-04-13Labeling · Supplement 16 · standardAP
1994-03-10Manufacturing (CMC) · Supplement 13 · standardAP
1993-05-28Labeling · Supplement 15 · standardAP
1991-11-08Manufacturing (CMC) · Supplement 14 · standardAP
1991-11-08Manufacturing (CMC) · Supplement 12 · standardAP
1979-04-04Type 1 - New Molecular Entity · Original · standardAP
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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