21
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 103951Orig1s5173 CHEMISTRY REVIEW(S)

CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of

  • Upload
    vuthu

  • View
    215

  • Download
    1

Embed Size (px)

Citation preview

Page 1: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

103951Orig1s5173

CHEMISTRY REVIEW(S)

Page 2: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 3: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 4: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 5: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 6: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 7: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 8: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 9: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 10: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 11: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 12: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 13: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 14: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 15: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 16: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 17: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 18: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 19: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 20: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of
Page 21: CHEMISTRY REVIEW(S) - Food and Drug Administration · PDF fileCHEMISTRY REVIEW(S) Amgen PAS 103951-5173 ... Manufacturing, Drug Substance and Drug Product ... or other procedures of