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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208261Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 208261Orig1s000€¦ · Recommendation: Approval Dru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable NDA 208261 Review 1 Oct 23,

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208261Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 208261Orig1s000€¦ · Recommendation: Approval Dru Name/Dosa e Form Stren th Route of Administration Rx/OTC Dis ensed A licant US a ent, if a licable NDA 208261 Review 1 Oct 23,
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