FDA.reportPublic FDA data

Application 077157

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL12.5MG;50MGNoNo
002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL12.5MG;100MGNoNo
003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL25MG;100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7367Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7367Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7367Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7367Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7367Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7367Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7367Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7367Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7367Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7368Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7368Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7368Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7368Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7368Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7368Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7368Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7368Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7368Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7369Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7369Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7369Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7369Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7369Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7369Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7369Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7369Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7369Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
33261-838Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAidarex Pharmaceuticals LLCANDACurrent
33261-950Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAidarex Pharmaceuticals LLCANDACurrent
42708-036Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideQPharma IncANDACurrent
42708-036Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideQPharma IncANDACurrent
42708-036Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideQPharma IncANDACurrent
50090-5295Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5475Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
63187-347Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-347Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-347Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-552Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-552Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
66116-450Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideMedVantx, Inc.ANDACurrent
68071-4518Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4518Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4518Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4518Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0602Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0602Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
72189-098LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent
72189-098LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent
72189-098LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent
72189-098LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent
72189-098LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent
72189-098LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent
72189-098LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent
72189-098LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9012ORIG2010-04-09