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FDA ANDA · ANDA078112

DIDANOSINE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA078112
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-08
LATEST ACTION
2012-01-31
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued

Products

DIDANOSINEDiscontinued
DIDANOSINE 10MG/ML · FOR SOLUTION · ORAL

Approval history

2012-01-31Labeling · Supplement 4AP
2011-12-27Labeling · Supplement 3AP
2010-03-29Labeling · Supplement 2AP
2007-03-08OriginalLetterAP
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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