FDA.reportPublic FDA data

Application 207631

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NILUTAMIDENILUTAMIDETABLET;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62559-173NilutamideNilutamideANI Pharmaceuticals, Inc.ANDACurrent
62559-173NilutamideNilutamideANI Pharmaceuticals, Inc.ANDACurrent
62559-173NilutamideNilutamideANI Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62858ORIG2020-05-08
40590ORIG2016-07-21
32859ORIG2016-07-19