FDA.reportPublic FDA data

Application 020636

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIRAMUNENEVIRAPINETABLET;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0046ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0046ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0046ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
53808-0808ViramunenevirapineState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71313SUPPL2022-06-15
71312SUPPL2022-06-15
71284SUPPL2022-06-13
57682ORIG2019-02-15
55742SUPPL2018-10-01
55615SUPPL2018-09-25
55613SUPPL2018-09-25
47768SUPPL2017-03-29
47735SUPPL2017-03-28
25413SUPPL2014-01-28
12906SUPPL2014-01-28
35050SUPPL2012-11-15
25412SUPPL2012-11-13
2966SUPPL2011-11-14
35049SUPPL2011-11-10
25411SUPPL2011-05-10
2965SUPPL2011-03-31
12905SUPPL2011-03-28
25410SUPPL2011-01-14
35048SUPPL2011-01-10
2964SUPPL2010-07-23
35047SUPPL2010-07-22
25409SUPPL2010-01-26
12904SUPPL2010-01-20
2963SUPPL2008-06-30
35045SUPPL2008-06-26
35046SUPPL2007-08-17
25408SUPPL2007-08-17
41513SUPPL2007-08-06
20797SUPPL2007-08-06
20795SUPPL2007-08-06
20793SUPPL2007-08-06
20792SUPPL2007-08-06
25407SUPPL2007-04-20
12903SUPPL2007-04-20
20796SUPPL2005-04-27
35044SUPPL2005-03-02
2962SUPPL2005-03-02
35040SUPPL2004-06-30
25404SUPPL2004-06-30
25403SUPPL2004-06-30
12902SUPPL2004-05-27
2961SUPPL2004-05-26
20794SUPPL2004-02-04
35043SUPPL2003-12-29
2960SUPPL2003-12-23
35042SUPPL2003-08-06
25406SUPPL2003-08-06
35041SUPPL2003-04-04
25405SUPPL2002-03-27