FDA.reportPublic FDA data

Application 078832

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAMIPRILRAMIPRILCAPSULE;ORAL1.25MGNoNo
002RAMIPRILRAMIPRILCAPSULE;ORAL2.5MGNoNo
003RAMIPRILRAMIPRILCAPSULE;ORAL5MGNoNo
004RAMIPRILRAMIPRILCAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60687-321RamiprilRamiprilAmerican Health PackagingANDACurrent
60687-321RamiprilRamiprilAmerican Health PackagingANDACurrent
60687-321RamiprilRamiprilAmerican Health PackagingANDACurrent
60687-332RamiprilRamiprilAmerican Health PackagingANDACurrent
60687-332RamiprilRamiprilAmerican Health PackagingANDACurrent
60687-343RamiprilRamiprilAmerican Health PackagingANDACurrent
60687-343RamiprilRamiprilAmerican Health PackagingANDACurrent
60687-354RamiprilRamiprilAmerican Health PackagingANDACurrent
60687-354RamiprilRamiprilAmerican Health PackagingANDACurrent
60687-354RamiprilRamiprilAmerican Health PackagingANDACurrent
60760-632RamiprilRamiprilSt. Mary's Medical Park PharmacyANDACurrent
60760-633RamiprilRamiprilSt. Mary's Medical Park PharmacyANDACurrent
65841-655RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-655RamiprilRamiprilZydus Lifesciences LimitedANDACurrent
65841-655RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-655RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-656RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-656RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-656RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-656RamiprilRamiprilZydus Lifesciences LimitedANDACurrent
65841-657RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-657RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-657RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-657RamiprilRamiprilZydus Lifesciences LimitedANDACurrent
65841-658RamiprilRamiprilZydus Lifesciences LimitedANDACurrent
65841-658RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-658RamiprilRamiprilCadila Healthcare LimitedANDACurrent
65841-658RamiprilRamiprilCadila Healthcare LimitedANDACurrent
68001-140RamiprilRamiprilBluePoint LaboratoriesANDACurrent
68001-140RamiprilRamiprilBluePoint LaboratoriesANDACurrent
68001-141RamiprilRamiprilBluePoint LaboratoriesANDACurrent
68001-141RamiprilRamiprilBluePoint LaboratoriesANDACurrent
68001-142RamiprilRamiprilBluePoint LaboratoriesANDACurrent
68001-142RamiprilRamiprilBluePoint LaboratoriesANDACurrent
68001-143RamiprilRamiprilBluePoint LaboratoriesANDACurrent
68001-143RamiprilRamiprilBluePoint LaboratoriesANDACurrent
68382-144RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-144RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-144RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-144RamiprilRamiprilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-145RamiprilRamiprilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-145RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-145RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-145RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-146RamiprilRamiprilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-146RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-146RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-146RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-147RamiprilRamiprilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-147RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-147RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-147RamiprilRamiprilZydus Pharmaceuticals (USA) Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23923ORIG2008-09-19