FDA.reportPublic FDA data

Application 075298

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUTAMIDEFLUTAMIDECAPSULE;ORAL125MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-753FlutamideFlutamidePar Pharmaceutical, Inc.ANDACurrent
49884-753FlutamideFlutamidePar Pharmaceutical, Inc.ANDACurrent
49884-753FlutamideFlutamidePar Pharmaceutical, Inc.ANDACurrent
49884-753FlutamideFlutamidePar Pharmaceutical, Inc.ANDACurrent
60429-272FlutamideFlutamideGolden State Medical Supply, Inc.ANDACurrent
60429-272FlutamideFlutamideGolden State Medical Supply, Inc.ANDACurrent
60429-272FlutamideFlutamideGolden State Medical Supply, Inc.ANDACurrent
60429-272FlutamideFlutamideGolden State Medical Supply, Inc.ANDACurrent
60429-272FlutamideFlutamideGolden State Medical Supply, Inc.ANDACurrent
80725-600EulexinFlutamideWaylis Therapeutics LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8605ORIG2004-06-04
30841ORIG2003-04-11