FDA.reportPublic FDA data

Application 205347

Type
ANDA
Sponsor
SQUARE PHARMS LTD

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
10135-768ValsartanValsartanMarlex Pharmaceuticals, Inc.ANDACurrent
10135-769ValsartanValsartanMarlex Pharmaceuticals, Inc.ANDACurrent
10135-770ValsartanValsartanMarlex Pharmaceuticals, Inc.ANDACurrent
10135-771ValsartanValsartanMarlex Pharmaceuticals, Inc.ANDACurrent
72819-181ValsartanvalsartanArchis Pharma LLCANDACurrent
72819-181ValsartanvalsartanArchis Pharma LLCANDACurrent
72819-182ValsartanvalsartanArchis Pharma LLCANDACurrent
72819-182ValsartanvalsartanArchis Pharma LLCANDACurrent
72819-183ValsartanvalsartanArchis Pharma LLCANDACurrent
72819-183ValsartanvalsartanArchis Pharma LLCANDACurrent
72819-184ValsartanvalsartanArchis Pharma LLCANDACurrent
72819-184ValsartanvalsartanArchis Pharma LLCANDACurrent
76483-023ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-023ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-023ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-023ValsartanValsartanSquare Pharmaceuticals Ltd.ANDACurrent
76483-024ValsartanValsartanSquare Pharmaceuticals Ltd.ANDACurrent
76483-024ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-024ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-024ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-025ValsartanValsartanSquare Pharmaceuticals Ltd.ANDACurrent
76483-025ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-025ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-025ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-026ValsartanValsartanSquare Pharmaceuticals Ltd.ANDACurrent
76483-026ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-026ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent
76483-026ValsartanValsartanSQUARE PHARMACEUTICALS LIMITEDANDACurrent