APPLICATION
ANDA090788
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-08
LATEST ACTION
2019-12-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
DIDANOSINEDiscontinued
DIDANOSINE 400MG · CAPSULE, DELAYED REL PELLETS · ORAL
DIDANOSINEDiscontinued
DIDANOSINE 200MG · CAPSULE, DELAYED REL PELLETS · ORAL
DIDANOSINEDiscontinued
DIDANOSINE 250MG · CAPSULE, DELAYED REL PELLETS · ORAL
DIDANOSINEDiscontinued
DIDANOSINE 125MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2019-12-06Labeling · Supplement 8 · standardAP
2019-12-06Labeling · Supplement 4 · standardAP
2019-12-06Labeling · Supplement 7 · standardAP
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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