Application 202266

Type
ANDA
Sponsor
CELLTRION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATETABLET;ORALEQ 75MG BASENoNo
002CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATETABLET;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-314ClopidogrelClopidogrelWockhardt LimitedANDACurrent
55648-315ClopidogrelClopidogrelWockhardt LimitedANDACurrent
64679-314ClopidogrelClopidogrelWockhardt USA LLC.ANDACurrent
64679-315ClopidogrelClopidogrelWockhardt USA LLC.ANDACurrent