210598orig1s000 · one 175mcg/3ml batch will be phced on the stability program annually after...

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210598Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

210598Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 3: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 4: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 5: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 6: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 7: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 8: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 9: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 10: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 11: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 12: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 13: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

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Page 14: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 15: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 16: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

Page 17: 210598Orig1s000 · One 175mcg/3mL batch Will be phced on the stability program annually after commercial productbn. Routine stability progam: batch sanples are phced at long term

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