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FDA ANDA · ANDA065152

CEPHALEXIN

Sponsor: CHARTWELL RX

APPLICATION
ANDA065152
TYPE
ANDA
ORIGINAL APPROVAL
2005-02-24
LATEST ACTION
2011-09-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CEPHALEXINPrescription
CEPHALEXIN EQ 250MG BASE · CAPSULE · ORAL
CEPHALEXINPrescription
CEPHALEXIN EQ 500MG BASE · CAPSULE · ORAL

Approval history

2011-09-20Labeling · Supplement 1AP
2005-02-24OriginalAP
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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