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FDA ANDA · ANDA065229

CEPHALEXIN

Sponsor: LUPIN

APPLICATION
ANDA065229
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-25
LATEST ACTION
2008-09-15
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

2008-09-15Labeling · Supplement 4AP
2005-11-25OriginalAP
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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