FDA.reportPublic FDA data

Application 022142

Type
NDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYMFIEFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL600MG;300MG;300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49502-475SYMFIEfavirenz, Lamivudine and Tenofovir Disoproxil FumarateMylan Specialty L.P.NDACurrent
49502-475SYMFIEfavirenz, Lamivudine and Tenofovir Disoproxil FumarateMylan Specialty L.P.NDACurrent
49502-475SYMFIEfavirenz, Lamivudine and Tenofovir Disoproxil FumarateMylan Specialty L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60725SUPPL2019-10-30
60714SUPPL2019-10-30
56559ORIG2018-11-26
6950ORIG2018-03-26
53141ORIG2018-03-22
62974ORIG1900-01-01