FDA.reportPublic FDA data

Application 090920

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOL VALERATEESTRADIOL VALERATEINJECTABLE;INJECTION20MG/MLNoNo
002ESTRADIOL VALERATEESTRADIOL VALERATEINJECTABLE;INJECTION40MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-0420ESTRADIOL VALERATEESTRADIOL VALERATEAmerican Regent, Inc.ANDACurrent
0517-0420ESTRADIOL VALERATEESTRADIOL VALERATEAmerican Regent, Inc.ANDACurrent
0517-0440ESTRADIOL VALERATEESTRADIOL VALERATEAmerican Regent, Inc.ANDACurrent
0517-0440ESTRADIOL VALERATEESTRADIOL VALERATEAmerican Regent, Inc.ANDACurrent
0574-0870ESTRADIOL VALERATEESTRADIOL VALERATEPerrigo CompanyANDACurrent
0574-0870ESTRADIOL VALERATEESTRADIOL VALERATEPerrigo CompanyANDACurrent
0574-0870ESTRADIOL VALERATEESTRADIOL VALERATEPerrigo CompanyANDACurrent
0574-0872ESTRADIOL VALERATEESTRADIOL VALERATEPerrigo CompanyANDACurrent
0574-0872ESTRADIOL VALERATEESTRADIOL VALERATEPerrigo CompanyANDACurrent
0574-0872ESTRADIOL VALERATEESTRADIOL VALERATEPerrigo CompanyANDACurrent