`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`212640Orig1s000
`
`OFFICER/EMPLOYEE LIST
`
`
`
`
`
`MEMORANDUM
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`DATE:
`
`November 25, 2019
`
`TO:
`
`FROM:
`
`Administrative file for NDA 212640
`
`Michelle Mathers, Regulatory Health Project Manager/Neurology 1 Group
`Division of Regulatory Operations for Neuroscience/Office of Regulatory
`Operations/CDER
`
`SUBJECT: Officer/Employee List for NDA 212640
`
`APPLICATION/DRUG:
`
`NDA 212640/Exservan (riluzole) oral soluble film 50mg
`
`The following officers or employees of FDA participated in the decision to approve this
`application and consented to be identified on this list:
`
`Basting, Eric
`Chelliah, Mariappan
`Chidambaram, Nallaperumal
`Choi, Young M.
`Dave, Kaushalkumar
`Heimann, Martha
`Gottipati, Gopichand
`Mada, Sripal
`Mathers, Michelle
`Paine, Rainer
`Rider, Briana
`Sabarinath, Sreedharan
`Shah, Sapna
`Tran, Suong
`Walters, Dahlia
`Williams, Sharon
`Wilson, Wendy
`Zhou, Tianhong Tim
`
`
`
`Reference ID: 4525245Reference ID: 4525554
`
`
`
`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`MICHELLE W MATHERS
`11/25/2019 03:51:26 PM
`
`
`
`Reference ID: 4525245Reference ID: 4525554
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
