FDA.reportPublic FDA data

Application 075636

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOVASTATINLOVASTATINTABLET;ORAL10MGNoNo
002LOVASTATINLOVASTATINTABLET;ORAL20MGNoNo
003LOVASTATINLOVASTATINTABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0070LovastatinLovastatinEon Labs, Inc.ANDACurrent
0185-0070LovastatinLovastatinEon Labs, Inc.ANDACurrent
0185-0072LovastatinLovastatinEon Labs, Inc.ANDACurrent
0185-0072LovastatinLovastatinEon Labs, Inc.ANDACurrent
0185-0074LovastatinLovastatinEon Labs, Inc.ANDACurrent
0185-0074LovastatinLovastatinEon Labs, Inc.ANDACurrent
50090-2278LovastatinLovastatinA-S Medication SolutionsANDACurrent
61919-676LOVASTATINLOVASTATINDIRECT RXANDACurrent
61919-676LOVASTATINLOVASTATINDIRECT RXANDACurrent
66267-555LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
66267-555LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
67046-450LovastatinLovastatinContract Pharmacy Services-PAANDACurrent
67046-451LovastatinLovastatinContract Pharmacy Services-PAANDACurrent
67544-106LovastatinLovastatinAphena Pharma Solutions -ANDACurrent
67544-225LovastatinLovastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-225LovastatinLovastatinAphena Pharma Solutions -ANDACurrent
67544-245LovastatinLovastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-245LovastatinLovastatinAphena Pharma Solutions -ANDACurrent
68001-214LovastatinLovastatinBluePoint LaboratoriesANDACurrent
68001-224LovastatinLovastatinBluePoint LaboratoriesANDACurrent
68071-1973LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3397LovastatinLovastatinNuCare Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22492ORIG2005-07-22