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FDA ANDA · ANDA077275

DIDANOSINE

Sponsor: AUROBINDO

APPLICATION
ANDA077275
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-14
LATEST ACTION
2012-08-14
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

DIDANOSINEDiscontinued
DIDANOSINE 150MG · TABLET, FOR SUSPENSION · ORAL
DIDANOSINEDiscontinued
DIDANOSINE 200MG · TABLET, FOR SUSPENSION · ORAL
DIDANOSINEDiscontinued
DIDANOSINE 100MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2012-08-14OriginalAP
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