FDA.reportPublic FDA data

Application 078605

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7426Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7426Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7426Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7426Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7426Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7426Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7426Montelukast SodiumMontelukast SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7748Montelukast SodiumMontelukast SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42708-042Montelukast SodiumMontelukast SodiumQPharma IncANDACurrent
42708-042Montelukast SodiumMontelukast SodiumQPharma IncANDACurrent
42708-042Montelukast SodiumMontelukast SodiumQPharma IncANDACurrent
54458-890MontelukastMontelukastInternational Laboratories, LLCANDACurrent
63187-289Montelukast SodiumMontelukast SodiumProficient Rx LPANDACurrent
63187-289Montelukast SodiumMontelukast SodiumProficient Rx LPANDACurrent
66116-503Montelukast SodiumMontelukast SodiumMedVantx, Inc.ANDACurrent
70518-0684Montelukast SodiumMontelukast SodiumREMEDYREPACK INC.ANDACurrent
70518-0684Montelukast SodiumMontelukast SodiumREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9173ORIG2012-08-06