Ganciclovir Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2003-08-27
License(s)
ANDA
RxNORM
ORAL CAPSULE\GANCICLOVIR
FDAOB
ORAL\CAPSULE\GANCICLOVIR
SPL Active
ORAL\CAPSULE\GANCICLOVIR
SPL Moiety
ORAL\CAPSULE\GANCICLOVIR

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633040636ANDARnabaxy Pharmaceuticals Inc.2003-08-27GANCICLOVIRORALCAPSULEANDA0764573406db8a-5ae9-4120-94bd-036701adbeca

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633040637ANDARnabaxy Pharmaceuticals Inc.2003-08-27GANCICLOVIRORALCAPSULEANDA0764573406db8a-5ae9-4120-94bd-036701adbeca

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076457GANCICLOVIRTrueRANBAXY LABORATORIES LTD2003-06-27ANDA076457_001, ANDA076457_002
2NDA020460CYTOVENETrueROCHE PALO ALTO LLC1994-12-22NDA020460_001, NDA020460_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA076457_001discontinuedGANCICLOVIR (250MG)ORALCAPSULEFalse2003-06-27GANCICLOVIR
2ANDA076457_002discontinuedGANCICLOVIR (500MG)ORALCAPSULEFalse2003-06-27GANCICLOVIR
3NDA020460_001discontinuedGANCICLOVIR (250MG)ORALCAPSULEFalse1994-12-22CYTOVENE
4NDA020460_002discontinuedGANCICLOVIR (500MG)ORALCAPSULEFalse1997-12-12CYTOVENE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13406db8a-5ae9-4120-94bd-036701adbeca (view SPL)GANCICLOVIR CAPSULESRx onlyFOR ORAL ADMINISTRATIONprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.manufacture2011-10-201633040636, 633040637

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