FDA.report

Application 075551

Type
ANDA
Sponsor
TEVA

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0576LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0576LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0576LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0576LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0576LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0576LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0926LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0926LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0926LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0926LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0926LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0926LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0928LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0928LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0928LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0928LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0928LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0928LovastatinLovastatinTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-3216LovastatinLovastatinA-S Medication SolutionsANDACurrent
50090-3216LovastatinLovastatinA-S Medication SolutionsANDACurrent
50090-3216LovastatinLovastatinA-S Medication SolutionsANDACurrent
50090-3268LovastatinLovastatinA-S Medication SolutionsANDACurrent
51407-251LovastatinLovastatinGolden State Medical Supply Inc.ANDACurrent
51407-251LovastatinLovastatinGolden State Medical SupplyANDACurrent
51407-251LovastatinLovastatinGolden State Medical SupplyANDACurrent
51407-251LovastatinLovastatinGolden State Medical SupplyANDACurrent
51407-252LovastatinLovastatinGolden State Medical SupplyANDACurrent
51407-252LovastatinLovastatinGolden State Medical SupplyANDACurrent
51407-252LovastatinLovastatinGolden State Medical Supply Inc.ANDACurrent
51407-252LovastatinLovastatinGolden State Medical SupplyANDACurrent
51407-253LovastatinLovastatinGolden State Medical Supply Inc.ANDACurrent
51407-253LovastatinLovastatinGolden State Medical SupplyANDACurrent
51407-253LovastatinLovastatinGolden State Medical SupplyANDACurrent
51407-253LovastatinLovastatinGolden State Medical SupplyANDACurrent
53002-5701LovastatinLovastatinRPK Pharmaceuticals, Inc.ANDACurrent
54458-844LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-844LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-845LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-845LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-846LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-846LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-870LovastatinLovastatinInternational Laboratories, LLCANDACurrent
54458-870LovastatinLovastatinInternational Laboratories, LLCANDACurrent
54458-871LovastatinLovastatinInternational Laboratories, LLCANDACurrent
54458-871LovastatinLovastatinInternational Laboratories, LLCANDACurrent
54458-914LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-915LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
54458-916LOVASTATINLOVASTATINInternational Laboratories, LLCANDACurrent
63629-1464LovastatinLovastatinBryant Ranch PrepackANDACurrent
68071-2653LovastatinLovastatinNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3064LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70518-3064LovastatinLovastatinREMEDYREPACK INC.ANDACurrent
70934-750LovastatinLovastatinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-755LovastatinLovastatinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-440LovastatinLovastatinProficient Rx LPANDACurrent
71610-396LovastatinLovastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.Date
430020ORIG12005-07-22