FDA.reportPublic FDA data

Application 209721

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL100MG;150MGNoNo
002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL133MG;200MGNoNo
003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL167MG;250MGNoNo
004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL200MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-439Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAvKAREANDACurrent
42291-439Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAvKAREANDACurrent
60219-2092Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
60219-2093Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
60219-2094Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
60219-2095Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
60219-2095Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
60219-2095Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
60219-2095Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1527Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals LLCANDACurrent
69238-1527Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1527Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1547Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals LLCANDACurrent
69238-1547Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1547Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1548Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1548Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1548Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals LLCANDACurrent
69238-1549Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals LLCANDACurrent
69238-1549Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-1549Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2092Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2092Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2092Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2093Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2093Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2093Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2094Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2094Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2094Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2095Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2095Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent
69238-2095Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55405ORIG2018-09-07