FDA.reportPublic FDA data

Application 040326

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOLESTRADIOLTABLET;ORAL0.5MGNoNo
002ESTRADIOLESTRADIOLTABLET;ORAL1MGNoNo
003ESTRADIOLESTRADIOLTABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0073EstradiolestradiolKAISER FOUNDATION HOSPITAANDACurrent
0378-1452EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-1452EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-1454EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-1454EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-1458EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-1458EstradiolestradiolMylan Pharmaceuticals Inc.ANDACurrent
50090-2624EstradiolestradiolA-S Medication SolutionsANDACurrent
55289-603EstradiolestradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-603EstradiolestradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-603EstradiolestradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-761EstradiolestradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-761EstradiolestradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-761EstradiolestradiolPD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38883ORIG2004-06-03
22126ORIG2003-07-31
29928ORIG1999-04-21