FDA.reportPublic FDA data

Application 208261

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEPATIERELBASVIR; GRAZOPREVIRTABLET;ORAL50MG;100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3074ZEPATIERelbasvir and grazoprevirMerck Sharp & Dohme Corp.NDACurrent
0006-3074ZEPATIERelbasvir and grazoprevirMerck Sharp & Dohme Corp.NDACurrent
0006-3074ZEPATIERelbasvir and grazoprevirMerck Sharp & Dohme Corp.NDACurrent
0006-3074ZEPATIERelbasvir and grazoprevirMerck Sharp & Dohme Corp.NDACurrent
0006-3074ZEPATIERelbasvir and grazoprevirMerck Sharp & Dohme LLCNDACurrent
0006-3074ZEPATIERelbasvir and grazoprevirMerck Sharp & Dohme Corp.NDACurrent
0006-3074ZEPATIERelbasvir and grazoprevirMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69552SUPPL2021-12-14
69533SUPPL2021-12-13
61255SUPPL2019-12-12
61242SUPPL2019-12-12
54827SUPPL2018-07-06
54772SUPPL2018-07-05
50402SUPPL2017-11-14
50383SUPPL2017-11-13
47245SUPPL2017-02-16
47244SUPPL2017-02-16
46853SUPPL2017-01-17
46806SUPPL2017-01-11
44973ORIG2016-03-08
43545ORIG2016-03-08
19989ORIG2016-02-02
10652ORIG2016-01-29