208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation:...
62
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208341Orig1s000 CHEMISTRY REVIEW(S)
Transcript of 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation:...
![Page 1: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/1.jpg)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
208341Orig1s000
CHEMISTRY REVIEW(S)
![Page 2: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/2.jpg)
![Page 3: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/3.jpg)
![Page 4: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/4.jpg)
![Page 5: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/5.jpg)
![Page 6: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/6.jpg)
![Page 7: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/7.jpg)
![Page 8: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/8.jpg)
![Page 9: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/9.jpg)
![Page 10: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/10.jpg)
![Page 11: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/11.jpg)
![Page 12: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/12.jpg)
![Page 13: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/13.jpg)
![Page 14: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/14.jpg)
![Page 15: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/15.jpg)
![Page 16: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/16.jpg)
![Page 17: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/17.jpg)
![Page 18: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/18.jpg)
![Page 19: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/19.jpg)
![Page 20: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/20.jpg)
![Page 21: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/21.jpg)
![Page 22: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/22.jpg)
![Page 23: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/23.jpg)
![Page 24: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/24.jpg)
![Page 25: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/25.jpg)
![Page 26: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/26.jpg)
![Page 27: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/27.jpg)
![Page 28: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/28.jpg)
![Page 29: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/29.jpg)
![Page 30: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/30.jpg)
![Page 31: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/31.jpg)
![Page 32: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/32.jpg)
![Page 33: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/33.jpg)
![Page 34: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/34.jpg)
![Page 35: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/35.jpg)
![Page 36: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/36.jpg)
![Page 37: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/37.jpg)
![Page 38: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/38.jpg)
![Page 39: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/39.jpg)
![Page 40: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/40.jpg)
![Page 41: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/41.jpg)
![Page 42: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/42.jpg)
![Page 43: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/43.jpg)
![Page 44: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/44.jpg)
![Page 45: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/45.jpg)
![Page 46: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/46.jpg)
![Page 47: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/47.jpg)
![Page 48: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/48.jpg)
![Page 49: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/49.jpg)
![Page 50: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/50.jpg)
![Page 51: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/51.jpg)
![Page 52: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/52.jpg)
![Page 53: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/53.jpg)
![Page 54: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/54.jpg)
![Page 55: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/55.jpg)
![Page 56: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/56.jpg)
![Page 57: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/57.jpg)
![Page 58: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/58.jpg)
![Page 59: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/59.jpg)
![Page 60: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/60.jpg)
![Page 61: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/61.jpg)
![Page 62: 208341Orig1s000 - Food and Drug Administration208341Orig1s000 CHEMISTRY REVIEW(S) Recommendation: Dru Name/Dosa e Form Stren th Route of Administration ... 400mg / 100 mg Oral Gilead](https://reader033.fdocuments.in/reader033/viewer/2022041711/5e48540f1cb21e527c083f1e/html5/thumbnails/62.jpg)