FDA.reportPublic FDA data

Application 206619

Type
NDA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIEKIRA PAK (COPACKAGED)DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIRTABLET, TABLET;ORAL250.0MG;12.5MG;75.0MG;EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3093Viekira PakDasabuvir and Ombitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent
0074-3093Viekira PakDasabuvir and Ombitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent
0074-3093Viekira PakDasabuvir and Ombitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent
0074-3093Viekira PakDasabuvir and Ombitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent
0074-3093Viekira PakDasabuvir and Ombitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61207SUPPL2019-12-10
61197SUPPL2019-12-09
61196SUPPL2019-12-09
55360SUPPL2018-08-29
55357SUPPL2018-08-29
54975SUPPL2018-07-25
50396SUPPL2017-11-13
50378SUPPL2017-11-13
47675SUPPL2017-03-24
47674SUPPL2017-03-24
47649SUPPL2017-03-23
47648SUPPL2017-03-23
47219SUPPL2017-02-15
47212SUPPL2017-02-15
40562SUPPL2016-06-23
10587SUPPL2016-06-23
40560SUPPL2016-04-27
10585SUPPL2016-04-26
40561SUPPL2016-02-01
10586SUPPL2016-01-29
10584SUPPL2015-10-26
40559SUPPL2015-10-23
19728SUPPL2015-10-15
32819SUPPL2015-10-14
19727SUPPL2015-07-22
10583SUPPL2015-07-22
40558SUPPL2015-03-26
32818SUPPL2015-03-26
44947ORIG2015-01-23
23024ORIG2015-01-23
40557ORIG2014-12-23
32817ORIG2014-12-23