Didanosine Oral Solution

Brand(s)
Videx
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bristol-Myers Squibb Company (2015-08-01)
Oldest Current Product
1991-10-09
License(s)
NDA
RxNORM
ORAL SOLUTION\DIDANOSINE
FDAOB
ORAL\FOR SOLUTION\DIDANOSINE
SPL Active
ORAL\POWDER, FOR SOLUTION\DIDANOSINE
SPL Moiety
ORAL\POWDER, FOR SOLUTION\DIDANOSINE

product(s) by strength(s)

didanosine 20 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000876632VidexNDABristol-Myers Squibb Company1991-10-09DIDANOSINEORALPOWDER, FOR SOLUTIONNDA020156d4401ca0-98ae-af38-84c7-2f615d0706b9

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA078112DIDANOSINEAUROBINDO PHARMA LTD2007-03-08ANDA078112_001
2NDA020155VIDEXTrueBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE1991-10-09NDA020155_003, NDA020155_004, NDA020155_005, NDA020155_006
3NDA020156VIDEXBRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE1991-10-09NDA020156_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078112_001RXDIDANOSINE (10MG/ML)ORALFOR SOLUTIONFalseAA2007-03-08DIDANOSINE
2NDA020155_003discontinuedDIDANOSINE (100MG/PACKET)ORALFOR SOLUTIONFalse1991-10-09VIDEX
3NDA020155_004discontinuedDIDANOSINE (167MG/PACKET)ORALFOR SOLUTIONFalse1991-10-09VIDEX
4NDA020155_005discontinuedDIDANOSINE (250MG/PACKET)ORALFOR SOLUTIONFalse1991-10-09VIDEX
5NDA020155_006discontinuedDIDANOSINE (375MG/PACKET)ORALFOR SOLUTIONFalse1991-10-09VIDEX
6NDA020156_001RXDIDANOSINE (10MG/ML)ORALFOR SOLUTIONTrueAA1991-10-09VIDEX

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1d4401ca0-98ae-af38-84c7-2f615d0706b9 (view SPL)These highlights do not include all the information needed to use VIDEX safely and effectively. See full prescribing information for VIDEX. VIDEX (didanosine, USP) pediatric powder for oral solutionInitial U.S. Approval: 1991prescriptionHuman PrescriptionBristol-Myers Squibb Company2015-08-0116000876632, 000876633

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII