FDA.reportPublic FDA data

Application 206894

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL600MG;200MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69097-210efavirenz, emtricitabine and tenofovir disoproxil fumarateefavirenz, emtricitabine and tenofovir disoproxil fumarateCipla USA Inc.ANDACurrent
69097-210efavirenz, emtricitabine and tenofovir disoproxil fumarateefavirenz, emtricitabine and tenofovir disoproxil fumarateCipla USA Inc.ANDACurrent
76282-678efavirenz, emtricitabine and tenofovir disoproxil fumarateefavirenz, emtricitabine and tenofovir disoproxil fumarateExelan Pharmaceuticals, Inc.ANDACurrent