FDA.reportPublic FDA data

Application 201593

Type
ANDA
Sponsor
TORRENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 5MG BASE;12.5MG;160MGNoNo
002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 5MG BASE;25MG;160MGNoNo
003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 10MG BASE;12.5MG;160MGNoNo
004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 10MG BASE;25MG;160MGNoNo
005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 10MG BASE;25MG;320MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13668-325Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideTorrent Pharmaceuticals LimitedANDACurrent
13668-325Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideTorrent Pharmaceuticals LimitedANDACurrent
13668-326Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideTorrent Pharmaceuticals LimitedANDACurrent
13668-326Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideTorrent Pharmaceuticals LimitedANDACurrent
13668-327Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideTorrent Pharmaceuticals LimitedANDACurrent
13668-327Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideTorrent Pharmaceuticals LimitedANDACurrent
13668-328Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideTorrent Pharmaceuticals LimitedANDACurrent
13668-328Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideTorrent Pharmaceuticals LimitedANDACurrent
13668-329Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideTorrent Pharmaceuticals LimitedANDACurrent
13668-329Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideTorrent Pharmaceuticals LimitedANDACurrent
70518-1220Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1220Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32121ORIG2015-06-10
32120ORIG2014-11-04