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Last Updated: July 13, 2024

Details for New Drug Application (NDA): 209511


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NDA 209511 describes XARACOLL, which is a drug marketed by Innocoll Pharms and is included in one NDA. There are two patents protecting this drug. Additional details are available on the XARACOLL profile page.

The generic ingredient in XARACOLL is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 209511
Tradename:XARACOLL
Applicant:Innocoll Pharms
Ingredient:bupivacaine hydrochloride
Patents:2
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrength100MG
Approval Date:Aug 28, 2020TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 9, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:May 20, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR INDUCING A POST-SURGICAL ANALGESIA SPARING EFFECT BY IMPLANTING AT THE SURGICAL SITE A COLLAGEN SPONGE CONTAINING BUPIVACAINE HCL WHICH PROVIDES LOCAL ANESTHESIA FOR UP TO 24 HOURS FOLLOWING IMPLANTATION

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