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FDA ANDA · ANDA090094

DIDANOSINE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA090094
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-24
LATEST ACTION
2019-11-14
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

2019-11-14Labeling · Supplement 14 · standardAP
2019-11-14Labeling · Supplement 13 · standardAP
2012-01-31Labeling · Supplement 9AP
2011-12-27Labeling · Supplement 8AP
2010-03-22Labeling · Supplement 6AP
2009-09-02Labeling · Supplement 5AP
2008-11-14Labeling · Supplement 1AP
2008-09-24Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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