valganciclovir Oral Tablet

Brand(s)
Valcyte
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-04-30)
Oldest Current Product
2001-03-29
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\VALGANCICLOVIR
FDAOB
ORAL\TABLET\VALGANCICLOVIR HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\VALGANCICLOVIR HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\GANCICLOVIR

product(s) by strength(s)

valganciclovir 450 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000040038ValcyteNDAGenentech, Inc.2001-03-29VALGANCICLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDNDA021304dc548ff9-e8ea-4d6e-b9b4-e31f53ac4078

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006036330ANDAQualitest Pharmaceuticals2014-11-04VALGANCICLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA20079037b7a5d8-9a2c-40b1-a414-71ecc47e567d
2551110762ANDADr. Reddy'S Laboratories Ltd2014-12-15VALGANCICLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA203511f37c0780-b953-46c2-d7d4-959fc2c3e571

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680840965ANDAAmerican Health Packaging2015-01-15VALGANCICLOVIR HYDROCHLORIDEORALTABLET, FILM COATED551110762ANDA2035114db6dd63-e56b-45a4-86b2-ee125a1854a0

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA200790VALGANCICLOVIR HYDROCHLORIDEENDO PHARMACEUTICALS INC2014-11-04ANDA200790_001
2ANDA203511VALGANCICLOVIR HYDROCHLORIDEDR REDDYS LABORATORIES LTD2014-11-04ANDA203511_001
3NDA021304VALCYTEHOFFMANN LA ROCHE INC2001-03-29p6083953, TREATMENT OF CMV RETINITIS/ PREVENTION OF CMV DISEASE IN KIDNEY, SUBSTANCENEW PATIENT POPULATION [2018-04-23]
EXTENDED THE DURATION OF THE DOSING REGIMEN FROM 100 DAYS TO 200 DAYS POST-TRANSPLANTATION FOR THE PREVENTION OF CMV DISEASE IN PEDIATRIC KIDNEY TRANSPLANT [2018-04-23]
NDA021304_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA200790_001RXVALGANCICLOVIR HYDROCHLORIDE (EQ 450MG BASE)ORALTABLETFalseAB2014-11-04VALGANCICLOVIR HYDROCHLORIDE
2ANDA203511_001RXVALGANCICLOVIR HYDROCHLORIDE (EQ 450MG BASE)ORALTABLETFalseAB2014-11-04VALGANCICLOVIR HYDROCHLORIDE
3NDA021304_001RXVALGANCICLOVIR HYDROCHLORIDE (EQ 450MG BASE)ORALTABLETTrueAB2001-03-29VALCYTE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6083953 (view patent)2015-03-29NDA021304, NDA022257valganciclovir Oral Solution

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
137b7a5d8-9a2c-40b1-a414-71ecc47e567d (view SPL)These highlights do not include all the information needed to useValganciclovir Tablets, USP safely and effectively. See full prescribing information for Valganciclovir Tablets, USP. VALGANCICLOVIR tablets USP, for oral useInitial U.S. Approval: 2001prescriptionHuman PrescriptionQualitest Pharmaceuticals2015-05-1510006036330
24db6dd63-e56b-45a4-86b2-ee125a1854a0 (view SPL)These highlights do not include all the information needed to use valganciclovir safely and effectively. See full prescribing information for valganciclovir. VALGANCICLOVIR Tablets USP, for oral useInitial U.S. Approval: 2001prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-01-141680840965
3dc548ff9-e8ea-4d6e-b9b4-e31f53ac4078 (view SPL)These highlights do not include all the information needed to use VALCYTE safely and effectively. See full prescribing information for VALCYTE. VALCYTE (valganciclovir hydrochloride) tablets, VALCYTE (valganciclovir hydrochloride) for oral solution Initial U.S. Approval: 2001prescriptionHuman PrescriptionGenentech, Inc.API MANUFACTURE2015-04-309000040038, 000040039valganciclovir Oral Solution
4f37c0780-b953-46c2-d7d4-959fc2c3e571 (view SPL)These highlights do not include all the information needed to use valganciclovir safely and effectively. See full prescribing information for valganciclovir. VALGANCICLOVIR Tablets USP, for oral use Initial U.S. Approval: 2001prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2014-02-154551110762

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