替扎尼定（Tizanidine）胶囊的NDA审评（FDA）.pdfVIP

TheserecordsarefromCDER’shistoricalfileofinformation

previouslydisclosedundertheFreedomofInformationAct(FOIA)

forthisdrugapprovalandarebeingpostedasis.Theyhavenot

beenpreviouslypostedonDrugs@FDAbecauseofthequality

(e.g.,readability)ofsomeoftherecords.Thedocumentswere

redactedbeforeamendmentstoFOIArequiredthatthevolumeof

redactedinformationbeidentifiedand/ortheFOIAexemptionbe

cited.Thesearethebestavailablecopies.

NOA-828397FIR:ATHENANEUROSCIENCES1OF7

TRADENAE:ZANAFLEMORALTABS.40

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ApprovalLetter

_-dRelated

Correspondence

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