FDA.reportPublic FDA data

Application 075182

Type
ANDA
Sponsor
MYLAN TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.1MG/24HRNoNo
002ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.075MG/24HRNoNo
003ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.025MG/24HRNoNo
004ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.0375MG/24HRNoNo
005ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.06MG/24HRNoNo
006ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.05MG/24HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3349EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3349EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3350EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3350EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3351EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3351EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3352EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3352EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3360EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3360EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3361EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-3361EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30786SUPPL2006-07-21
8553SUPPL2006-07-21
22438ORIG2000-02-24
8552ORIG2000-02-24