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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:213687Orig1s000PRODUCT QUALITY REVIEW(S)5(&200(1\'$$7,21SSURYDO ASSURED ELK 3RVW0DUNHWLQJ &RPPLWPHQW & RESOW 5HVSRQVH1\'$ $VVHVVPHQW \'USJ
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