`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`212535Orig1s000
`
`
`
`
`OFFICER/EMPLOYEE LIST
`
`
`
`MEMORANDUM:
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICE
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`12/13/2019
`
`Administrative file for NDA 212535
`
`
`DATE:
`
`TO:
`
`FROM:
`
`
`
`Thao Vu, Regulatory Project Manager
`Division of Gastroenterology and Inborn Errors Products (DGIEP), Office of Drug
`Evaluation III (ODE III)
`
`Officer/Employee list for NDA 212535
`
`
`SUBJECT:
`
`APPLICATION/DRUG: NDA 212535, NOURESS (cysteine hydrochloride injection) USP, 50 mg/mL
`
`The following officers or employees of FDA participated in the decision to approve this
`application and consented to be identified on this list:
`
`
`Soule, Lisa (Lisa.Soule@fda.hhs.gov)
`Liang, Qin
`Li, Xiaohui
`Wang, Jie
`Cai, Hong
`Liedtka, Jane
`Stevens-Riley, Marla
`Meyer, Joette M
`Sachs, Hari
`Abraham, Sherly
`Rychlik, Idalia
`Zhou, Tianhong Tim
`Perez, Lawrence
`Palmer, Dupeh
`Dinatale, Miriam
`Seo, Suna
`Barry, Oumou
`Dunson, Alvis
`Ramos, Fresnida
`Yancey, Carolyn L (OND)
`Joseph, David B
`
`
`
`Yes: 12/9/2019 3:51 PM
`Yes: 12/9/2019 2:35 PM
`Yes: 12/9/2019 12:56 PM
`Yes: 12/9/2019 12:56 PM
`Yes: 12/9/2019 12:55 PM
`Yes: 12/9/2019 12:54 PM
`Yes: 12/9/2019 12:53 PM
`Yes: 12/9/2019 12:51 PM
`Yes: 12/9/2019 12:48 PM
`Yes: 12/9/2019 12:47 PM
`Yes: 12/9/2019 12:47 PM
`Yes: 12/9/2019 12:42 PM
`Yes: 12/9/2019 12:41 PM
`Yes: 12/9/2019 12:41 PM
`Yes: 12/9/2019 12:41 PM
`Yes: 12/9/2019 1:53 PM
`Yes: 12/9/2019 1:12 PM
`Yes: 12/9/2019 1:03 PM
`Yes: 12/11/2019 8:33 AM
`Yes: 12/10/2019 1:20 PM
`Yes: 12/10/2019 1:06 PM
`
`Reference ID: 4534716
`
`