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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-401 PHARMACOLOGY REVIEW(S)

CENTER FOR DRUG EVALUATION AND RESEARCH · reviewer: g. jagadeesh. ph.d. fda nda no. 22.401 department of health and human services public health service food and drug administration

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Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH · reviewer: g. jagadeesh. ph.d. fda nda no. 22.401 department of health and human services public health service food and drug administration

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER: 22-401

PHARMACOLOGY REVIEW(S)

Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH · reviewer: g. jagadeesh. ph.d. fda nda no. 22.401 department of health and human services public health service food and drug administration
Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH · reviewer: g. jagadeesh. ph.d. fda nda no. 22.401 department of health and human services public health service food and drug administration

(b) (4)(b) (4)

Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH · reviewer: g. jagadeesh. ph.d. fda nda no. 22.401 department of health and human services public health service food and drug administration

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Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH · reviewer: g. jagadeesh. ph.d. fda nda no. 22.401 department of health and human services public health service food and drug administration
Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH · reviewer: g. jagadeesh. ph.d. fda nda no. 22.401 department of health and human services public health service food and drug administration