application number: anda 076466 - food and drug · pdf fileapplication number: anda 076466 ......

42
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: ANDA 076466 BIOEQUIVALENCE REVIEWS

Upload: vuongcong

Post on 24-Mar-2018

215 views

Category:

Documents


1 download

TRANSCRIPT

Page 1: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

ANDA 076466

BIOEQUIVALENCE REVIEWS

Page 2: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 3: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 4: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 5: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 6: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 7: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 8: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 9: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 10: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 11: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 12: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 13: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 14: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 15: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 16: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 17: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 18: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 19: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 20: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 21: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 22: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 23: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 24: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 25: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 26: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 27: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 28: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 29: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 30: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 31: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 32: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 33: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 34: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 35: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 36: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 37: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 38: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 39: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 40: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 41: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery
Page 42: APPLICATION NUMBER: ANDA 076466 - Food and Drug · PDF fileAPPLICATION NUMBER: ANDA 076466 ... Standard Method description Standard curve range Limit of quantitation Average recovery