FDA.report

Application 077912

Type
ANDA
Sponsor
LUPIN

Related Records

Application Products

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

NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-236Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
10544-237Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
10544-564LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEBlenheim Pharmacal, Inc.ANDACurrent
33261-416LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEAidarex Pharmaceuticals LLCANDACurrent
33261-728LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEAidarex Pharmaceuticals LLCANDACurrent
33261-828LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEAidarex Pharmaceuticals LLCANDACurrent
35356-777LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-777LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-777LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-777LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-777LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-777LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-777LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-778LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-778LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-778LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-778LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-778LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-778LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-778LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
42708-150Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideQPharma IncANDACurrent
43063-458Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-458Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-458Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-458Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-458Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-458Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-458Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-468Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, InANDACurrent
43063-468Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-468Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-468Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-468Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-468Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-468Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-482Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, InANDACurrent
43063-482Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-482Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-482Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-482Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-482Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-482Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-924LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-924LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDEQuality Care Products LLCANDACurrent
49999-924LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-924LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-924LISINOPRIL AND HYDROCHLOROTHIAZIDELISINOPRIL AND HYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1109Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1109Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1109Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2565Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2565Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2565Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2974Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2974Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2974Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2974Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2974Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50268-479Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideAvPAKANDACurrent
50268-479Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideAvPAKANDACurrent
50268-480Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideAvPAKANDACurrent
50268-480Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideAvPAKANDACurrent
50268-481Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideAvPAKANDACurrent
50268-481Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideAvPAKANDACurrent
50436-7000Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideUnit Dose ServicesANDACurrent
50436-8000Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideUnit Dose ServicesANDACurrent
50436-8900Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideUnit Dose ServicesANDACurrent
51655-412Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideNorthwind Pharmaceuticals, LLCANDACurrent
51655-413Lisinopril and HCTZLisinopril and HydrochlorothiazideNorthwind Pharmaceuticals, LLCANDACurrent
53002-1674Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideRPK Pharmaceuticals, Inc.ANDACurrent
53002-2308Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideRPK Pharmaceuticals, Inc.ANDACurrent
54458-886Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideInternational Laboratories, LLCANDACurrent
54458-886Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideInternational Laboratories, LLCANDACurrent
54458-991Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideInternational Laboratories, LLCANDACurrent
54458-991Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideInternational Laboratories, LLCANDACurrent
54458-992Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideInternational Laboratories, LLCANDACurrent
54458-992Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideInternational Laboratories, LLCANDACurrent
54458-993Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideInternational Laboratories, LLCANDACurrent
57297-518Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideLUPIN LIMITEDANDACurrent
57297-519Lisinopril and HydrochlorothiazideLisinopril and HydrochlorothiazideLUPIN LIMITEDANDACurrent

Documents

DocumentSubmission typeDate
43990ORIG2009-05-30
44629ORIG2006-10-10