FDA.reportPublic FDA data

Application 076265

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRILTABLET;ORAL12.5MG;10MGNoNo
002LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRILTABLET;ORAL12.5MG;20MGNoNo
003LISINOPRIL AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LISINOPRILTABLET;ORAL25MG;20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1262Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1262Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideWest-Ward Pharmaceuticals CorpANDACurrent
0143-1262Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1262Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1263Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1263Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1263Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideWest-Ward Pharmaceuticals CorpANDACurrent
0143-1263Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1264Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1264Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1264Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideWest-Ward Pharmaceuticals CorpANDACurrent
0143-1264Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
43353-800Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-975Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2086Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
52959-997Lisinopril with HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEH.J. Harkins Company, Inc.ANDACurrent
66267-751Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-751Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-752Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-752Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
67544-276Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-6364Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7389Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
70518-0081Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
71335-0284Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0284Lisinopril with HydrochlorothiazideLisinopril and HydrochlorothiazideBryant Ranch PrepackANDACurrent