CENTER FOR DRUG EVALUATION ANDRESEARCH

APPLICATIONNUMBER:

21-918

ADMINISTRATIVE and CORRESPONDENCEDOCUMENTS

NDAt#21-911

IXCLVSIVITY S1JMMAJlY

SUPPLt#NA

~N_. SALVAT,S.A.

Appmval Date, IfJCJlewJl May 1, 1009

'ART I

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