FDA.reportPublic FDA data

Application 090405

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LETROZOLELETROZOLETABLET; ORAL2.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-744letrozoleletrozoleCadila Healthcare LimitedANDACurrent
68382-363letrozoleletrozoleZydus Pharmaceuticals (USA) Inc.ANDACurrent