FDA.reportPublic FDA data

Application 076009

Type
ANDA
Sponsor
CHARTWELL MOLECULES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NABUMETONENABUMETONETABLET;ORAL500MGNoNo
002NABUMETONENABUMETONETABLET;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-273NabumetoneNabumetoneBlenheim Pharmacal, Inc.ANDACurrent
49884-649NabumetoneNabumetonePar Pharmaceutical IncANDACurrent
49884-650NabumetoneNabumetonePar Pharmaceutical IncANDACurrent
63874-607NabumetoneNabumetoneAltura Pharmaceuticals, Inc.ANDACurrent
63874-687NabumetoneNabumetoneAltura Pharmaceuticals, Inc.ANDACurrent