FDA.reportPublic FDA data

Application 022257

Type
NDA
Sponsor
HOFFMANN LA ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALCYTEVALGANCICLOVIR HYDROCHLORIDEFOR SOLUTION;ORAL50MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0039Valcytevalganciclovir hydrochlorideGenentech, Inc.NDACurrent
0004-0039Valcytevalganciclovir hydrochlorideGenentech, Inc.NDACurrent
0004-0039Valcytevalganciclovir hydrochlorideGenentech, Inc.NDACurrent
0004-0039Valcytevalganciclovir hydrochlorideGenentech, Inc.NDACurrent
0004-0039Valcytevalganciclovir hydrochlorideGenentech, Inc.NDACurrent
0004-0039Valcytevalganciclovir hydrochlorideGenentech, Inc.NDACurrent
0004-0039Valcytevalganciclovir hydrochlorideGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69788SUPPL2021-12-27
69759SUPPL2021-12-27
65354SUPPL2020-11-27
65336SUPPL2020-11-25
65159SUPPL2020-11-05
64986SUPPL2020-10-23
55101SUPPL2018-08-03
55099SUPPL2018-08-03
48833SUPPL2017-06-26
48824SUPPL2017-06-26
17162SUPPL2015-04-28
29485SUPPL2015-04-24
17161SUPPL2013-04-01
7126SUPPL2013-04-01
38456SUPPL2010-08-10
7125SUPPL2010-08-10
42471ORIG2010-05-27
24267ORIG2010-05-27
29484ORIG2009-09-01
17160ORIG2009-08-30
53034ORIG1900-01-01
53033ORIG1900-01-01