Details for New Drug Application (NDA): 209511
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The generic ingredient in XARACOLL is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Twenty 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: | RX | Dosage: | IMPLANT;IMPLANTATION | Strength | 100MG | ||||
Approval Date: | Aug 28, 2020 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 9, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | May 20, 2029 | Product 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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