FDA.reportPublic FDA data

Application 040851

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZONATATEBENZONATATECAPSULE;ORAL100MGNoNo
002BENZONATATEBENZONATATECAPSULE;ORAL150MGNoNo
003BENZONATATEBENZONATATECAPSULE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46672-280benzonatatebenzonatateMikart, LLCANDACurrent
46672-280benzonatatebenzonatateMikart, Inc.ANDACurrent
46672-281benzonatatebenzonatateMikart, LLCANDACurrent
46672-281benzonatatebenzonatateMikart, Inc.ANDACurrent
46672-282benzonatatebenzonatateMikart, LLCANDACurrent
46672-282benzonatatebenzonatateMikart, Inc.ANDACurrent
69499-329benzonatatebenzonatateSolubiomixANDACurrent
69499-329benzonatatebenzonatateSolubiomixANDACurrent
69499-329benzonatatebenzonatateSolubiomixANDACurrent
69499-329benzonatatebenzonatateSolubiomixANDACurrent