loader
Please Wait
Applying Filters...

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

Menu
$ API Ref.Price (USD/KG) : 174Xls 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 20581 TOPIRAMATE 2007-06-06 Active II Complete 2015-04-03 2013-05-21
26/09/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 19247 TOPIRAMATE USP 2006-03-04 Active II Complete 2013-09-10 2013-08-29