FDA.reportPublic FDA data

Application 078917

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BICALUTAMIDEBICALUTAMIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6019BicalutamideBicalutamideMajor PharmaceuticalsANDACurrent
0904-6019BicalutamideBicalutamideMajor PharmaceuticalsANDACurrent
0904-6019BicalutamideBicalutamideMajor PharmaceuticalsANDACurrent
16714-816BicalutamideBicalutamideNorthstar RxLLCANDACurrent
16714-816BicalutamideBicalutamideNorthstar RxLLCANDACurrent
16729-023BicalutamideBicalutamideAccord Healthcare Inc.ANDACurrent
16729-023BicalutamideBicalutamideAccord Healthcare Inc.ANDACurrent
16729-023BicalutamideBicalutamideAccord Healthcare Inc.ANDACurrent
60429-177BicalutamideBicalutamideGolden State Medical Supply, Inc.ANDACurrent
60429-177BicalutamideBicalutamideGolden State Medical Supply, Inc.ANDACurrent
60429-177BicalutamideBicalutamideGolden State Medical Supply, Inc.ANDACurrent
60429-177BicalutamideBicalutamideGolden State Medical Supply, Inc.ANDACurrent
60505-2642BicalutamideBicalutamideApotex Corp.ANDACurrent
63629-8308BicalutamideBicalutamideBryant Ranch PrepackANDACurrent
63629-8308BicalutamideBicalutamideBryant Ranch PrepackANDACurrent
70518-2993BicalutamideBicalutamideREMEDYREPACK INC.ANDACurrent
71205-577BicalutamideBicalutamideProficient Rx LPANDACurrent
71205-577BicalutamideBicalutamideProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39566ORIG2009-07-23
9196ORIG2009-07-09