APPLICATION
ANDA065248
TYPE
ANDA
ORIGINAL APPROVAL
2005-06-28
LATEST ACTION
2011-09-29
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
2011-09-29Labeling · Supplement 8AP
2006-03-08Labeling · Supplement 3AP
2005-06-28OriginalAP
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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