FDA.reportPublic FDA data

Application 079161

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL5MGNoNo
002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL10MGNoNo
003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL20MGNoNo
004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2201Rosuvastatin Calciumrosuvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-2201Rosuvastatin Calciumrosuvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-2203Rosuvastatin Calciumrosuvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-2203Rosuvastatin Calciumrosuvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-2204Rosuvastatin Calciumrosuvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-2204Rosuvastatin Calciumrosuvastatin calciumMylan Pharmaceuticals IncANDACurrent
0378-2232Rosuvastatin Calciumrosuvastatin calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-2232Rosuvastatin Calciumrosuvastatin calciumMylan Pharmaceuticals IncANDACurrent
42292-029Rosuvastatin Calciumrosuvastatin calciumMylan Institutional Inc.ANDACurrent
42292-030Rosuvastatin Calciumrosuvastatin calciumMylan Institutional Inc.ANDACurrent
42292-031Rosuvastatin Calciumrosuvastatin calciumMylan Institutional Inc.ANDACurrent
42292-032Rosuvastatin Calciumrosuvastatin calciumMylan Institutional Inc.ANDACurrent
50090-2458Rosuvastatin Calciumrosuvastatin calciumA-S Medication SolutionsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31417ORIG2016-07-20
9228ORIG2010-05-17