Please Wait
Applying Filters...

List of Drug Master Files (DMF) of Etodolac Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Menu
$ API Ref.Price (USD/KG) : 101Xls download

Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.

Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 11405 ETODOLAC 1995-03-29 Active II Complete 2014-12-16 2014-11-28
26/09/2024 Taro Pharmaceutical Industries
U.S.A
TARO PHARMACEUTICAL INDUSTRIES LTD 15339 ETODOLAC USP MICRONIZED 2001-04-13 Active II N/A