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FDA NDA · NDA050406

KEFLEX

Sponsor: PRAGMA

APPLICATION
NDA050406
TYPE
NDA
ORIGINAL APPROVAL
1971-01-04
LATEST ACTION
2026-03-05
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

KEFLEX · ReferenceDiscontinued
CEPHALEXIN EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · FOR SUSPENSION · ORAL
KEFLEX · ReferenceDiscontinued
CEPHALEXIN EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
KEFLEX · ReferenceDiscontinued
CEPHALEXIN EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · FOR SUSPENSION · ORAL

Approval history

2026-03-05Labeling · Supplement 14 · standard — Letter ↗AP
2018-12-18Labeling · Supplement 13 · standard — Label ↗AP
2009-05-19Labeling · Supplement 11 · standardAP
1996-05-15Labeling · Supplement 12 · standardAP
1995-02-13Labeling · Supplement 10 · standardAP
1992-08-27Labeling · Supplement 8AP
1990-04-10Labeling · Supplement 7AP
1971-01-04Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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