NDA 18692, held by Hospira. Bupivacaine Hydrochloride.
As of Nov 13, 2026, NDA 18692 (Marcaine), held by Hospira, was first approved by FDA on May 4, 1984, with 10 approved supplements and 0 published complete response letters.
MARCAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia). MARCAINE SPINAL is an amide-local anesthetic indicated in adults for subarachnoid injection for the production of subarachnoid block (spinal anesthesia).
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 1984 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Marcaine0.75% · injectable;spinal | Bupivacaine Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 2022 | Supplement 24Labeling · Standard review | Approved | |
| Nov 2, 2018 | Supplement 20Labeling · Standard review | Approved | |
| Sep 19, 2014 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jan 30, 2012 | Supplement 15Labeling · Standard review | Approved | |
| Feb 19, 2010 | Supplement 14Labeling | Approved | |
| Jun 12, 2003 | Supplement 7Labeling · Standard review | Approved | |
| Aug 21, 2001 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1999 | Supplement 2Labeling | Approved | None posted |
| Mar 9, 1999 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 26, 1987 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| May 4, 1984 | Original applicationNew dosage form · 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
