FDA.reportPublic FDA data

Application 075143

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYUREAHYDROXYUREACAPSULE;ORAL500MGNoNo
002HYDROXYUREAHYDROXYUREACAPSULE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0882HYDROXYUREAHydroxyureaTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0882HYDROXYUREAHydroxyureaTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0882HYDROXYUREAHydroxyureaTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0882HYDROXYUREAHydroxyureaTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0882HYDROXYUREAHydroxyureaTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0882HYDROXYUREAHydroxyureaTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0882HYDROXYUREAHydroxyureaTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0882HYDROXYUREAHydroxyureaTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0882HYDROXYUREAHydroxyureaTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-321HYDROXYUREAHydroxyureaAvKARE, Inc.ANDACurrent
42291-321HYDROXYUREAHydroxyureaAvKARE, Inc.ANDACurrent
42291-321HYDROXYUREAHydroxyureaAvKARE, Inc.ANDACurrent
42291-321HYDROXYUREAHydroxyureaAvKAREANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22432ORIG1998-10-16
8537ORIG1998-10-16