FDA.reportPublic FDA data

Application 022141

Type
NDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIMDUOLAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL300MG;300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49502-450CIMDUOLamivudine and Tenofovir Disoproxil FumarateMylan Specialty L.P.NDACurrent
49502-450CIMDUOLamivudine and Tenofovir Disoproxil FumarateMylan Specialty L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56577ORIG2018-11-27
54951SUPPL2018-07-23
52796ORIG2018-03-02
63113ORIG1900-01-01
63112ORIG1900-01-01