FDA.reportPublic FDA data

Application 204011

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALSARTANVALSARTANTABLET;ORAL40MGNoNo
002VALSARTANVALSARTANTABLET;ORAL80MGNoNo
003VALSARTANVALSARTANTABLET;ORAL160MGNoNo
004VALSARTANVALSARTANTABLET;ORAL320MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-856ValsartanValsartanAvKAREANDACurrent
42291-856ValsartanValsartanAvKAREANDACurrent
42291-857ValsartanValsartanAvKAREANDACurrent
42291-857ValsartanValsartanAvKAREANDACurrent
42291-858ValsartanValsartanAvKAREANDACurrent
42291-858ValsartanValsartanAvKAREANDACurrent
42291-859ValsartanValsartanAvKAREANDACurrent
42291-859ValsartanValsartanAvKAREANDACurrent
65162-837ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-837ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-837ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-837ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-837ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-837ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-837ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-838ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-838ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-838ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-838ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-838ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-838ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-838ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-839ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-839ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-839ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-839ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-839ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-839ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-839ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-840ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-840ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-840ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-840ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-840ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-840ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
65162-840ValsartanValsartanAmneal Pharmaceuticals LLCANDACurrent
70934-293ValsartanValsartanDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-293ValsartanValsartanDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent