FDA.reportPublic FDA data

Application 209011

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET, CHEWABLE;ORALEQ 4MG BASENoNo
002MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET, CHEWABLE;ORALEQ 5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58657-715Montelukast SodiumMontelukast SodiumMethod Pharmaceuticals, LLCANDACurrent
58657-715Montelukast SodiumMontelukast SodiumMethod Pharmaceuticals, LLCANDACurrent
58657-716Montelukast SodiumMontelukast SodiumMethod Pharmaceuticals, LLCANDACurrent
58657-716Montelukast SodiumMontelukast SodiumMethod Pharmaceuticals, LLCANDACurrent
69844-039MONTELUKAST SODIUMMONTELUKAST SODIUMGraviti Pharmaceuticals Private LimitedANDACurrent
69844-040MONTELUKAST SODIUMMONTELUKAST SODIUMGraviti Pharmaceuticals Private LimitedANDACurrent
69844-074MONTELUKAST SODIUMMONTELUKAST SODIUMGraviti Pharmaceuticals Private LimitedANDACurrent
69844-075MONTELUKAST SODIUMMONTELUKAST SODIUMGraviti Pharmaceuticals Private LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48075ORIG2017-04-21