Application 078921

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANASTROZOLEANASTROZOLETABLET;ORAL1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60687-112AnastrozoleAnastrozoleAmerican Health PackagingANDACurrent
60687-112AnastrozoleAnastrozoleAmerican Health PackagingANDACurrent
60687-112AnastrozoleAnastrozoleAmerican Health PackagingANDACurrent
60687-112AnastrozoleAnastrozoleAmerican Health PackagingANDACurrent
65841-743AnastrozoleAnastrozoleCadila Healthcare LimitedANDACurrent
65841-743AnastrozoleAnastrozoleCadila Healthcare LimitedANDACurrent
65841-743AnastrozoleAnastrozoleZydus Lifesciences LimitedANDACurrent
68001-155AnastrozoleAnastrozoleBluePoint LaboratoriesANDACurrent
68001-155AnastrozoleAnastrozoleBluePoint LaboratoriesANDACurrent
68001-155AnastrozoleAnastrozoleBluePoint LaboratoriesANDACurrent
68001-155AnastrozoleAnastrozoleBluePoint LaboratoriesANDACurrent
68382-209AnastrozoleAnastrozoleZydus Pharmaceuticals USA Inc.ANDACurrent
68382-209AnastrozoleAnastrozoleZydus Pharmaceuticals (USA) Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9197ORIG2010-06-30