FDA.reportPublic FDA data

Application 091226

Type
ANDA
Sponsor
MYLAN 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
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-3950Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3951Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3952Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3953Atorvastatin Calciumatorvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
43353-181Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-181Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-181Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-182Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-182Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-182Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-184Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-184Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-184Atorvastatin Calciumatorvastatin calciumAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-208Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-209Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-210Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
51079-211Atorvastatin Calciumatorvastatin calciumMylan Institutional Inc.ANDACurrent
55154-4384Atorvastatin Calciumatorvastatin calciumCardinal HealthANDACurrent
55154-4384Atorvastatin Calciumatorvastatin calciumCardinal HealthANDACurrent
55154-4384Atorvastatin Calciumatorvastatin calciumCardinal Health 107, LLCANDACurrent
55154-4384Atorvastatin Calciumatorvastatin calciumCardinal HealthANDACurrent
70518-0198Atorvastatin Calciumatorvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-0462Atorvastatin Calciumatorvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-0567Atorvastatin Calciumatorvastatin calciumREMEDYREPACK INC.ANDACurrent
70518-0567Atorvastatin Calciumatorvastatin calciumREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57221SUPPL2019-01-15
22723ORIG2015-03-09