FDA.reportPublic FDA data

Application 079166

Type
ANDA
Sponsor
TEVA PHARMS USA

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
0093-7571Rosuvastatin CalciumRosuvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7572Rosuvastatin CalciumRosuvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7573Rosuvastatin CalciumRosuvastatin CalciumTeva Pharmaceuticals USA, Inc.ANDACurrent
42708-111Rosuvastatin CalciumRosuvastatin CalciumQPharma IncANDACurrent
45865-893Rosuvastatin CalciumRosuvastatin Calciummedsource pharmaceuticalsANDACurrent
63187-869Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent
63187-869Rosuvastatin CalciumRosuvastatin CalciumProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31418ORIG2016-07-20
9230ORIG2010-05-17