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. Twenty-one suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
The generic ingredient in XARACOLL is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | IMPLANT;IMPLANTATION | Strength | 100MG | ||||
| Approval Date: | Aug 28, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 9, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | 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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