loader
Please Wait
Applying Filters...

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

Client Email Product
Menu
$ API Ref.Price (USD/KG) : 457Xls 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 Medichem S.A
Spain
MEDICHEM SA 18052 PAROXETINE HYDROCHLORIDE HEMIHYDRATE 2005-02-01 Active II Complete 2015-10-08 2015-09-14
26/09/2024 Apotex Pharmachem
Canada
APOTEX PHARMACHEM INC 21440 PAROXETINE HYDROCHLORIDE ANHYDROUS USP 2008-03-18 Active II N/A