FDA.reportPublic FDA data

Application 209012

Type
ANDA
Sponsor
CSPC OUYI

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
58657-717Montelukast sodiumMontelukast sodiumMethod Pharmaceuticals, LLCANDACurrent
58657-717Montelukast sodiumMontelukast sodiumMethod Pharmaceuticals, LLCANDACurrent
69844-041MONTELUKAST SODIUMMONTELUKAST SODIUMGraviti Pharmaceuticals Private LimitedANDACurrent
69844-041MONTELUKAST SODIUMMONTELUKAST SODIUMGraviti Pharmaceuticals Private LimitedANDACurrent
69844-076montelukast sodiummontelukast sodiumGraviti Pharmaceuticals Private LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48149ORIG2017-04-27