ZYNRELEF®（布比卡因和美洛昔康）缓释溶液的product quality review（FDA）.pdfVIP

CENTERFORDRUGEVALUATIONAND

RESEARCH

APPLICATIONNUMBER:

211988Orig1s000

PRODUCTQUALITYREVIEW(S)

ValerieDigitallysignedbyValerieAmspacher

AmspacherDate:2/18/202110:06:54AM

GUID:5714dbd10078d2d3d9b60a0ceb819fc3

ReferenceID:4748657ReferenceID:4799540

Establishedname(s)(bupivacaineandNotAcceptable.

meloxicam)extended-Reviseestablishedname

releasesolution.as(bupivacaineand

meloxicam)solution.

Route(s)ofadministrationNoinformationprovidedNotAcceptable.

inhighlightsofthePIRouteofadministration,

e.g.“forsofttissue

instillationandperiarticular

instillationuse”mustbe

includedafterthedosage

form,per21CFR

201.57(a)(2).

DosageFormsandStrengthsHeadinginHighlights

SummaryofthedosageZYNRELEFNotAcceptable.

form(s)andstrength(s)(bupivacaineand