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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207946Orig1s000 CHEMISTRY REVIEW(S)

207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate

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Page 1: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

207946Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 3: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 4: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 5: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 6: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 7: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 8: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 9: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 10: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 11: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 12: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 13: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 14: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
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Page 17: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 18: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
Page 19: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
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Page 21: 207946Orig1s000 - Food and Drug AdministrationDru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable CHEMISTRY REVIEW Paliperidone palmitate
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