FDA.reportPublic FDA data

Application 090245

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 5MG BASE;160MGNoNo
002AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 10MG BASE;160MGNoNo
003AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 5MG BASE;320MGNoNo
004AMLODIPINE BESYLATE AND VALSARTANAMLODIPINE BESYLATE; VALSARTANTABLET;ORALEQ 10MG BASE;320MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-880Amlodipine and ValsartanAmlodipine and Valsartanmedsource pharmaceuticalsANDACurrent
45865-882Amlodipine and ValsartanAmlodipine and Valsartanmedsource pharmaceuticalsANDACurrent
45865-889Amlodipine and ValsartanAmlodipine and Valsartanmedsource pharmaceuticalsANDACurrent
57297-764Amlodipine and ValsartanAmlodipine and ValsartanLUPIN LIMITEDANDACurrent
57297-765Amlodipine and ValsartanAmlodipine and ValsartanLUPIN LIMITEDANDACurrent
57297-766Amlodipine and ValsartanAmlodipine and ValsartanLUPIN LIMITEDANDACurrent
57297-767Amlodipine and ValsartanAmlodipine and ValsartanLUPIN LIMITEDANDACurrent
68180-764Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-764Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-764Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-764Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-764Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-765Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-765Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-765Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-765Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-765Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-766Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-766Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-766Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-766Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-766Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-767Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-767Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-767Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-767Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-767Amlodipine and ValsartanAmlodipine and ValsartanLupin Pharmaceuticals, Inc.ANDACurrent