FDA.reportPublic FDA data

Application 077837

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIMVASTATINSIMVASTATINTABLET;ORAL5MGNoNo
002SIMVASTATINSIMVASTATINTABLET;ORAL10MGNoNo
003SIMVASTATINSIMVASTATINTABLET;ORAL20MGNoNo
004SIMVASTATINSIMVASTATINTABLET;ORAL40MGNoNo
005SIMVASTATINSIMVASTATINTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-486SimvastatinSimvastatinBlenheim Pharmacal, Inc.ANDACurrent
10544-487SimvastatinSimvastatinBlenheim Pharmacal, Inc.ANDACurrent
50090-1387SimvastatinSimvastatinA-S Medication SolutionsANDACurrent
53808-0800SimvastatinSimvastatinState of Florida DOH Central PharmacyANDACurrent
63739-435SimvastatinSimvastatinMcKesson CorporationANDACurrent
63739-435SimvastatinSimvastatinMcKesson Corporation dba SKY PackagingANDACurrent
63739-436SimvastatinSimvastatinMcKesson CorporationANDACurrent
63739-436SimvastatinSimvastatinMcKesson Corporation dba SKY PackagingANDACurrent
63739-437SimvastatinSimvastatinMcKesson CorporationANDACurrent
63739-437SimvastatinSimvastatinMcKesson Corporation dba SKY PackagingANDACurrent
63739-438SimvastatinSimvastatinMcKesson CorporationANDACurrent
63739-438SimvastatinSimvastatinMcKesson Corporation dba SKY PackagingANDACurrent
65841-065SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-065SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-065SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-065SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-065SimvastatinSimvastatinZydus Lifesciences LimitedANDACurrent
65841-066SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-066SimvastatinSimvastatinZydus Lifesciences LimitedANDACurrent
65841-066SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-066SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-066SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-067SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-067SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-067SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-067SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-067SimvastatinSimvastatinZydus Lifesciences LimitedANDACurrent
65841-068SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-068SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-068SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-068SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-068SimvastatinSimvastatinZydus Lifesciences LimitedANDACurrent
65841-069SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-069SimvastatinSimvastatinZydus Lifesciences LimitedANDACurrent
65841-069SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-069SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
65841-069SimvastatinSimvastatinCadila Healthcare LimitedANDACurrent
67046-672SimvastatinSimvastatinContract Pharmacy Services-PAANDACurrent
67046-675SimvastatinSimvastatinContract Pharmacy Services-PAANDACurrent
68071-2092SimvastatinSimvastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68382-065SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-065SimvastatinSimvastatinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-065SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-065SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-065SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-066SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-066SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-066SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-066SimvastatinSimvastatinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-066SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-067SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-067SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-067SimvastatinSimvastatinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-067SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-067SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-068SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-068SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-068SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-068SimvastatinSimvastatinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-068SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-069SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-069SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-069SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-069SimvastatinSimvastatinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-069SimvastatinSimvastatinZydus Pharmaceuticals (USA) Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23888ORIG2011-05-26