FDA.reportPublic FDA data

Application 078103

Type
ANDA
Sponsor
LUPIN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7992SIMVASTATINSIMVASTATINNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7992SIMVASTATINSIMVASTATINNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7992SIMVASTATINSIMVASTATINNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7993SIMVASTATINSIMVASTATINNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7993SIMVASTATINSIMVASTATINNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7993SIMVASTATINSIMVASTATINNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8056SIMVASTATINSIMVASTATINNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8056SIMVASTATINSIMVASTATINNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8056SIMVASTATINSIMVASTATINNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50090-4736SIMVASTATINSIMVASTATINA-S Medication SolutionsANDACurrent
50090-4736SIMVASTATINSIMVASTATINA-S Medication SolutionsANDACurrent
50090-4901SIMVASTATINSIMVASTATINA-S Medication SolutionsANDACurrent
50090-5788SIMVASTATINSIMVASTATINA-S Medication SolutionsANDACurrent
50090-6236SIMVASTATINSIMVASTATINA-S Medication SolutionsANDACurrent
50090-6306SIMVASTATINSIMVASTATINA-S Medication SolutionsANDACurrent
53808-0790simvastatinSIMVASTATINDOH CENTRAL PHARMACYANDACurrent
53808-0791simvastatinSIMVASTATINDOH CENTRAL PHARMACYANDACurrent
53808-0794simvastatinSIMVASTATINDOH CENTRAL PHARMACYANDACurrent
55154-4782SimvastatinSimvastatinCardinal Health 107, LLCANDACurrent
55154-4782SimvastatinSimvastatinCardinal HealthANDACurrent
55154-4782SimvastatinSimvastatinCardinal HealthANDACurrent
55154-4782SimvastatinSimvastatinCardinal HealthANDACurrent
55700-426SIMVASTATINSIMVASTATINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-515SIMVASTATINSIMVASTATINLake Erie Medical DBA Quality Care Products LLCANDACurrent
57297-464SIMVASTATINSIMVASTATINLUPIN LIMITEDANDACurrent
57297-465SIMVASTATINSIMVASTATINLUPIN LIMITEDANDACurrent
57297-478SIMVASTATINSIMVASTATINLUPIN LIMITEDANDACurrent
57297-479SIMVASTATINSIMVASTATINLUPIN LIMITEDANDACurrent
57297-480SIMVASTATINSIMVASTATINLUPIN LIMITEDANDACurrent
57297-481SIMVASTATINSIMVASTATINLUPIN LIMITEDANDACurrent
57297-482SIMVASTATINSIMVASTATINLUPIN LIMITEDANDACurrent
60687-210SIMVASTATINSIMVASTATINAmerican Health PackagingANDACurrent
60687-210SimvastatinSimvastatinAmerican Health PackagingANDACurrent
60687-210SimvastatinSimvastatinAmerican Health PackagingANDACurrent
60687-210SimvastatinSimvastatinAmerican Health PackagingANDACurrent
61919-764SIMVASTATINSIMVASTATINDIRECT RXANDACurrent
61919-764SIMVASTATINSIMVASTATINDIRECT RXANDACurrent
61919-764SIMVASTATINSIMVASTATINDIRECT RXANDACurrent
61919-764SIMVASTATINSIMVASTATINDIRECT RXANDACurrent
61919-764SIMVASTATINSIMVASTATINDIRECT RXANDACurrent
68071-2250SIMVASTATINSIMVASTATINNuCare Pharmaceuticals.Inc.ANDACurrent
68071-4331SIMVASTATINSIMVASTATINNuCare Pharmaceuticals,Inc.ANDACurrent
68084-511SimvastatinSimvastatinAmerican Health PackagingANDACurrent
68084-511SimvastatinSimvastatinAmerican Health PackagingANDACurrent
68084-511SimvastatinSimvastatinAmerican Health PackagingANDACurrent
68084-511SimvastatinSimvastatinAmerican Health PackagingANDACurrent
68084-512SimvastatinSimvastatinAmerican Health PackagingANDACurrent
68084-512SimvastatinSimvastatinAmerican Health PackagingANDACurrent
68084-512SimvastatinSimvastatinAmerican Health PackagingANDACurrent
68084-512SimvastatinSimvastatinAmerican Health PackagingANDACurrent
68180-464SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-464SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-464SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-464SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-464SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-464SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-465SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-465SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-465SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-465SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-465SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-465SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-478SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-478SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-478SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-478SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-478SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-478SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-479SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-479SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-479SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-479SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-479SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-479SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-480SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-480SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-480SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-480SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-480SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent
68180-480SIMVASTATINSIMVASTATINLupin Pharmaceuticals, Inc.ANDACurrent