FDA.report

Application 078296

Type
ANDA
Sponsor
LUPIN

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001LOVASTATINLOVASTATINTABLET;ORAL10MGNoNo
002LOVASTATINLOVASTATINTABLET;ORAL20MGNoNo
003LOVASTATINLOVASTATINTABLET;ORAL40MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8151LovastatinlovastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8151LovastatinlovastatinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8152LovastatinlovastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8152LovastatinlovastatinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
21695-534LovastatinLovastatinRebel Distributors CorpANDACurrent
21695-535LovastatinLovastatinRebel Distributors CorpANDACurrent
21695-536LovastatinLovastatinRebel Distributors CorpANDACurrent
43063-493LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-493LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-493LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-493LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-493LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-471LovastatinLovastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-471LovastatinLovastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0759LovastatinlovastatinA-S Medication SolutionsANDACurrent
50090-0759LovastatinlovastatinA-S Medication SolutionsANDACurrent
50090-0762LovastatinlovastatinA-S Medication SolutionsANDACurrent
50090-0762LovastatinlovastatinA-S Medication SolutionsANDACurrent
50090-0762LovastatinlovastatinA-S Medication SolutionsANDACurrent
50090-3396LovastatinlovastatinA-S Medication SolutionsANDACurrent
50090-3396LovastatinlovastatinA-S Medication SolutionsANDACurrent
50090-3396LovastatinlovastatinA-S Medication SolutionsANDACurrent
51655-558LovastatinlovastatinNorthwind Pharmaceuticals, LLCANDACurrent
53002-1385LovastatinlovastatinRPK Pharmaceuticals, Inc.ANDACurrent
53002-1385LovastatinlovastatinRPK Pharmaceuticals, Inc.ANDACurrent
53217-304LovastatinlovastatinAidarex Pharmaceuticals LLCANDACurrent
54458-936LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-936LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-937LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-937LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-938LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-938LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
55289-692LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-692LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-692LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-692LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-692LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-692LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-881LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-881LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-881LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-881LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-881LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-881LovastatinlovastatinPD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-244LovastatinlovastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-244LovastatinlovastatinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-311LOVASTATINLOVASTATINDirect RxANDACurrent
61919-311LOVASTATINLOVASTATINDirect RxANDACurrent
61919-311LOVASTATINLOVASTATINDirect RxANDACurrent
63187-765LovastatinlovastatinProficient Rx LPANDACurrent
63187-765LovastatinlovastatinProficient Rx LPANDACurrent
63187-765LovastatinlovastatinProficient Rx LPANDACurrent
63187-765LovastatinlovastatinProficient Rx LPANDACurrent
63187-814LovastatinlovastatinProficient Rx LPANDACurrent
63187-814LovastatinlovastatinProficient Rx LPANDACurrent
63629-6346LovastatinlovastatinBryant Ranch PrepackANDACurrent
63629-6346LovastatinlovastatinBryant Ranch PrepackANDACurrent
63629-6386LovastatinlovastatinBryant Ranch PrepackANDACurrent
63629-6386LovastatinlovastatinBryant Ranch PrepackANDACurrent
63629-6436LovastatinlovastatinBryant Ranch PrepackANDACurrent
63629-6436LovastatinlovastatinBryant Ranch PrepackANDACurrent
63629-6436LovastatinlovastatinBryant Ranch PrepackANDACurrent
63629-6436LovastatinlovastatinBryant Ranch PrepackANDACurrent
68001-314LovastatinlovastatinBluePoint LaboratoriesANDACurrent
68001-314LovastatinlovastatinBluePoint LaboratoriesANDACurrent
68001-314LovastatinlovastatinBluePoint LaboratoriesANDACurrent
68001-315LovastatinlovastatinBluePoint LaboratoriesANDACurrent
68001-315LovastatinlovastatinBluePoint LaboratoriesANDACurrent
68001-315LovastatinlovastatinBluePoint LaboratoriesANDACurrent
68001-316LovastatinlovastatinBluePoint LaboratoriesANDACurrent
68001-316LovastatinlovastatinBluePoint LaboratoriesANDACurrent
68001-316LovastatinlovastatinBluePoint LaboratoriesANDACurrent
68071-1880LovastatinlovastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1880LovastatinlovastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3261LovastatinlovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3261LovastatinlovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3261LovastatinlovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4271LovastatinlovastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4271LovastatinlovastatinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4271LovastatinlovastatinNuCare Pharmaceuticals,Inc.ANDACurrent