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Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,

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Page 1: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 2: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 3: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 4: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 5: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 6: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 7: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 8: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 9: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 10: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 11: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 12: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 13: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 14: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 15: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 16: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 17: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 18: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 19: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 20: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 21: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 22: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 23: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 24: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,
Page 25: Summary Basis of Approval - Food and Drug Administration · Title: Summary Basis of Approval Author: CBER Subject: licensed name = Alteplase Keywords: CBER, Approval, Activase, Genentech,