FDA.reportPublic FDA data

Application 019951

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETROVIRZIDOVUDINEINJECTABLE;INJECTION10MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent
49702-213RETROVIRzidovudineViiV Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80882SUPPL 2025-01-21
80881SUPPL 2025-01-21
65921SUPPL2021-01-19
63638SUPPL2019-12-20
55437SUPPL2018-09-12
55426SUPPL2018-09-11
50551SUPPL2017-12-01
50528SUPPL2017-11-29
48023SUPPL2017-04-14
48007SUPPL2017-04-13
47440SUPPL2017-03-03
47363SUPPL2017-02-28
12095SUPPL2015-01-08
19882SUPPL2014-12-31
34134SUPPL2012-06-06
19881SUPPL2012-06-05
1847SUPPL2011-11-28
34133SUPPL2011-11-25
1846SUPPL2006-11-22
34132SUPPL2006-07-13
1845SUPPL2006-07-13
1843SUPPL2004-06-16
1844SUPPL2003-08-15
34131SUPPL2003-08-14
12094SUPPL2003-08-06
12093SUPPL2003-06-10
1842SUPPL2002-02-21