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FDA ANDA · ANDA062791

CEPHALEXIN

Sponsor: SUN PHARM INDS (IN)

APPLICATION
ANDA062791
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-11
LATEST ACTION
2011-09-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2011-09-29Labeling · Supplement 7AP
2009-01-26Labeling · Supplement 5AP
1996-07-15Labeling · Supplement 3AP
1995-10-23Labeling · Supplement 2AP
1994-10-04Labeling · Supplement 1AP
1987-06-11OriginalAP
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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