FDA.reportPublic FDA data

Application 074582

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DANAZOLDANAZOLCAPSULE;ORAL200MGNoYes
002DANAZOLDANAZOLCAPSULE;ORAL100MGNoNo
003DANAZOLDANAZOLCAPSULE;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0633DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0633DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0633DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0633DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0633DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0633DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0634DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0634DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0634DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0634DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0634DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0634DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0635DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0635DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0635DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0635DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0635DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0635DanazolDanazolTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-243DanazolDanazolAvKARE, Inc.ANDACurrent
42291-243DanazolDanazolAvKAREANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42856ORIG2003-08-01