NDA 20997, held by Purdue Pharma LP. Levobupivacaine Hydrochloride.
As of Nov 13, 2026, NDA 20997 (Chirocaine), held by Purdue Pharma LP, was first approved by FDA on Aug 5, 1999, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 5, 1999 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ChirocaineEQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Levobupivacaine Hydrochloride | DiscontinuedReference drug |
| ChirocaineEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Levobupivacaine Hydrochloride | DiscontinuedReference drug |
| ChirocaineEQ 7.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Levobupivacaine Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 2, 1999 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 5, 1999 | Original applicationNew active ingredient · Standard review | Approved |
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
