FDA.reportPublic FDA data

Application 090955

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONTELUKAST SODIUMMONTELUKAST SODIUMGRANULE;ORALEQ 4MG BASE/PACKETNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7487Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7487Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7487Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7487Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7487Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7487Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7487Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9307ORIG2012-08-06