FDA.reportPublic FDA data

Application 205519

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASENoNo
002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 20MG BASENoNo
003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 40MG BASENoNo
004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMTABLET;ORALEQ 80MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-649ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMarlex Pharmaceuticals IncANDACurrent
10135-650ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMarlex Pharmaceuticals IncANDACurrent
10135-651ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMarlex Pharmaceuticals IncANDACurrent
10135-653ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMarlex Pharmaceuticals IncANDACurrent
50228-451ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-451ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-451ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-451ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-451ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-451ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-451ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-452ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-452ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-452ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-452ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-452ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-452ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-452ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-453ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-454ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-454ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-454ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-454ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-454ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-454ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
50228-454ATORVASTATIN CALCIUMATORVASTATIN CALCIUMScieGen Pharmaceuticals, Inc.ANDACurrent
51407-078ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply Inc.ANDACurrent
51407-078ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-078ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-078ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical SupplyANDACurrent
51407-078ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical SupplyANDACurrent
51407-078ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-078ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-078ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-079ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply Inc.ANDACurrent
51407-079ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-079ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-079ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical SupplyANDACurrent
51407-079ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical SupplyANDACurrent
51407-079ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-079ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-079ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-080ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply Inc.ANDACurrent
51407-080ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-080ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-080ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical SupplyANDACurrent
51407-080ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical SupplyANDACurrent
51407-080ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-080ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-080ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-081ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply Inc.ANDACurrent
51407-081ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-081ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-081ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical SupplyANDACurrent
51407-081ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical SupplyANDACurrent
51407-081ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-081ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
51407-081ATORVASTATIN CALCIUMATORVASTATIN CALCIUMGolden State Medical Supply, Inc.ANDACurrent
53217-319ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAidarex Pharmaceuticals LLCANDACurrent
63187-907ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPANDACurrent
63187-907ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPANDACurrent
63187-907ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPANDACurrent
63629-8469ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackANDACurrent
63629-8469ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackANDACurrent
63629-8470ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackANDACurrent
63629-8470ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackANDACurrent
63629-8471ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackANDACurrent
63629-8471ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackANDACurrent
63629-8472ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackANDACurrent
63629-8472ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch PrepackANDACurrent
67046-334ATORVASTATIN CALCIUMATORVASTATIN CALCIUMCoupler EnterprisesANDACurrent
68071-1553ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1695ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1885ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10457ORIG2016-05-24