FDA.reportPublic FDA data

Application 200889

Type
ANDA
Sponsor
SANDOZ INC

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
0781-5560MontelukastMontelukastSandoz IncANDACurrent
0781-5560MontelukastMontelukastSandoz IncANDACurrent
0781-5560MontelukastMontelukastSandoz IncANDACurrent
0781-5560MontelukastMontelukastSandoz IncANDACurrent
63629-4886MontelukastMontelukastBryant Ranch PrepackANDACurrent
63629-4886MontelukastMontelukastBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9851ORIG2012-08-06