NDA 209511, held by Innocoll Pharms. Bupivacaine Hydrochloride.
As of Nov 13, 2026, NDA 209511 (Xaracoll), held by Innocoll Pharms, was first approved by FDA on Aug 28, 2020, with 0 approved supplements and 1 published complete response letter.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2020 | Original applicationTYPE 3/4 · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Nov 30, 2018 | NDA 209511Nonclinical, Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xaracoll100MG · implant;implantation | Bupivacaine Hydrochloride | DiscontinuedReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
