Ganciclovir Injectable Solution

Brand(s)
Cytovene
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2010-08-03)
Oldest Current Product
1989-06-23
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\GANCICLOVIR
FDAOB
INJECTION\INJECTION\GANCICLOVIR SODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\GANCICLOVIR SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\GANCICLOVIR

product(s) by strength(s)

ganciclovir 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000046940CytoveneNDAGenentech, Inc.1989-06-23GANCICLOVIR SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA01966138e8f819-985c-4d20-aafd-3ba953af26ca

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230315ANDAApp Pharmaceuticals, Llc2010-06-28GANCICLOVIR SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA09065835addab5-09db-4f8a-9c69-6fbce33ecc37, b47f5d1c-36b8-49b6-a410-3b3f4661dde7

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076222GANCICLOVIR SODIUMTrueEUROHEALTH INTERNATIONAL SARL2003-07-16ANDA076222_001
2ANDA090658GANCICLOVIRFRESENIUS KABI USA LLC2010-06-21ANDA090658_001
3ANDA202624GANCICLOVIRLUITPOLD PHARMACEUTICALS INC2013-09-18ANDA202624_001
4NDA019661CYTOVENEROCHE PALO ALTO LLC1989-06-23NDA019661_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA076222_001discontinuedGANCICLOVIR SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalse2003-07-16GANCICLOVIR SODIUM
2ANDA090658_001RXGANCICLOVIR SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2010-06-21GANCICLOVIR
3ANDA202624_001RXGANCICLOVIR SODIUM (EQ 500MG BASE/VIAL)INJECTIONFalseAP2013-09-18GANCICLOVIR
4NDA019661_001RXGANCICLOVIR SODIUM (EQ 500MG BASE/VIAL)INJECTIONTrueAP1989-06-23CYTOVENE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
135addab5-09db-4f8a-9c69-6fbce33ecc37 (view SPL)prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-04-032633230315
238e8f819-985c-4d20-aafd-3ba953af26ca (view SPL)CYTOVENE-IV (ganciclovir sodium for injection)prescriptionHuman PrescriptionGenentech, Inc.API MANUFACTURE, MANUFACTURE2010-08-036000046940
3b47f5d1c-36b8-49b6-a410-3b3f4661dde7 (view SPL)prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2010-06-301633230315

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