center for drug evaluation and research · 10/17/2008, "the chemistry, manufacturing and...
TRANSCRIPT
![Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted](https://reader034.vdocument.in/reader034/viewer/2022051915/60073219e3597051187bfdda/html5/thumbnails/1.jpg)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER: 22-203
CROSS DISCIPLINE TEAM LEADER REVIEW
![Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted](https://reader034.vdocument.in/reader034/viewer/2022051915/60073219e3597051187bfdda/html5/thumbnails/2.jpg)
![Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted](https://reader034.vdocument.in/reader034/viewer/2022051915/60073219e3597051187bfdda/html5/thumbnails/3.jpg)
![Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted](https://reader034.vdocument.in/reader034/viewer/2022051915/60073219e3597051187bfdda/html5/thumbnails/4.jpg)
![Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted](https://reader034.vdocument.in/reader034/viewer/2022051915/60073219e3597051187bfdda/html5/thumbnails/5.jpg)
![Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted](https://reader034.vdocument.in/reader034/viewer/2022051915/60073219e3597051187bfdda/html5/thumbnails/6.jpg)
![Page 7: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted](https://reader034.vdocument.in/reader034/viewer/2022051915/60073219e3597051187bfdda/html5/thumbnails/7.jpg)
TRANSCRIPT
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER: 22-203
CROSS DISCIPLINE TEAM LEADER REVIEW