FDA.reportPublic FDA data

Application 078214

Type
ANDA
Sponsor
LANNETT

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1368DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1368DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1368DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1368DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1392DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1392DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1392DanazolDanazolLannett Company, Inc.ANDACurrent
0527-1392DanazolDanazolLannett Company, Inc.ANDACurrent
71205-861DanazolDanazolProficient Rx LPANDACurrent