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FDA ANDA · ANDA065326

CEPHALEXIN

Sponsor: CHARTWELL RX

APPLICATION
ANDA065326
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-10
LATEST ACTION
2011-09-29
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

CEPHALEXINDiscontinued
CEPHALEXIN EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL
CEPHALEXINDiscontinued
CEPHALEXIN EQ 125MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

2011-09-29Labeling · Supplement 4AP
2006-07-10OriginalAP
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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