FDA.reportPublic FDA data

Application 202468

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
52343-037Montelukast SodiumMontelukast SodiumACETRIS HEALTH, LLCANDACurrent
52343-037Montelukast SodiumMontelukast SodiumACETRIS HEALTH, LLCANDACurrent
53808-0920Montelukast SodiumMontelukast SodiumState of Florida DOH Central PharmacyANDACurrent
57237-255Montelukast SodiumMontelukast SodiumRising Health, LLCANDACurrent
57237-255Montelukast SodiumMontelukast SodiumRising Health, LLCANDACurrent
57237-255Montelukast SodiumMontelukast SodiumRising Health, LLCANDACurrent
57237-255Montelukast SodiumMontelukast SodiumRising Health, LLCANDACurrent
57237-255Montelukast SodiumMontelukast SodiumRising Health, LLCANDACurrent
65862-574Montelukast SodiumMontelukast SodiumAurobindo Pharma LimitedANDACurrent
65862-574Montelukast SodiumMontelukast SodiumAurobindo Pharma LimitedANDACurrent
65862-574Montelukast SodiumMontelukast SodiumAurobindo Pharma LimitedANDACurrent
65862-574Montelukast SodiumMontelukast SodiumAurobindo Pharma LimitedANDACurrent
65862-574Montelukast SodiumMontelukast SodiumAurobindo Pharma LimitedANDACurrent
65862-574Montelukast SodiumMontelukast SodiumAurobindo Pharma LimitedANDACurrent
71610-129Montelukast SodiumMontelukast SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10057ORIG2012-08-06