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FDA NDA · NDA050405

KEFLEX

Sponsor: PRAGMA

APPLICATION
NDA050405
TYPE
NDA
ORIGINAL APPROVAL
1971-01-04
LATEST ACTION
2019-09-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

KEFLEX · ReferenceDiscontinued
CEPHALEXIN EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
KEFLEX · ReferenceDiscontinued
CEPHALEXIN EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
KEFLEX · ReferenceDiscontinued
CEPHALEXIN EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
KEFLEX · ReferenceDiscontinued
CEPHALEXIN EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2019-09-06Labeling · Supplement 110 · standard — Label ↗AP
2018-12-19Labeling · Supplement 108 · standard — Label ↗AP
2018-12-18Labeling · Supplement 107 · standard — Label ↗AP
2015-10-30Labeling · Supplement 106 · standard — Label ↗AP
2013-12-30Manufacturing (CMC) · Supplement 104AP
2008-09-16Labeling · Supplement 101 · standard — Letter ↗AP
2008-05-21Labeling · Supplement 99 · standard — Letter ↗AP
2006-05-12Efficacy · Supplement 97 · unknown — Letter ↗AP
2004-11-19Labeling · Supplement 92 · standard — Letter ↗AP
2004-06-25Labeling · Supplement 95 · standard — Letter ↗AP
2004-01-15Labeling · Supplement 94 · standard — Label ↗AP
2002-10-23Manufacturing (CMC) · Supplement 93AP
2001-07-27Manufacturing (CMC) · Supplement 91AP
1996-05-15Labeling · Supplement 90 · standardAP
1995-02-13Labeling · Supplement 89 · standardAP
1992-08-27Labeling · Supplement 15AP
1991-10-09Manufacturing (CMC) · Supplement 16AP
1990-04-10Labeling · Supplement 14AP
1988-11-04Manufacturing (CMC) · Supplement 88AP
1988-09-21Labeling · Supplement 13AP
1987-03-04Labeling · Supplement 11AP
1987-03-04Manufacturing (CMC) · Supplement 10AP
1987-02-17Efficacy · Supplement 12AP
1986-08-29Labeling · Supplement 9AP
1986-08-21Efficacy · Supplement 5AP
1985-11-22Labeling · Supplement 4AP
1985-11-04Manufacturing (CMC) · Supplement 3AP
1984-09-05Manufacturing (CMC) · Supplement 1AP
1977-05-25Manufacturing (CMC) · Supplement 87AP
1977-04-28Manufacturing (CMC) · Supplement 86AP
1977-04-22Labeling · Supplement 85AP
1977-03-15Manufacturing (CMC) · Supplement 84AP
1977-03-09Manufacturing (CMC) · Supplement 83AP
1977-02-28Labeling · Supplement 82AP
1976-12-17Labeling · Supplement 81AP
1976-12-10Manufacturing (CMC) · Supplement 80AP
1976-12-10Manufacturing (CMC) · Supplement 79AP
1976-09-08Labeling · Supplement 78AP
1976-09-08Labeling · Supplement 77AP
1976-09-02Labeling · Supplement 76AP
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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