NDA 18304, held by Fresenius Kabi USA. Bupivacaine Hydrochloride, Bupivacaine Hydrochloride; Epinephrine Bitartrate.
As of Nov 14, 2026, NDA 18304 (Sensorcaine), held by Fresenius Kabi USA, was first approved by FDA on Dec 30, 1981, with 26 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 1981 | Original application | Approved | None posted |
| Sensorcaine0.25% · injectable;injection | Bupivacaine Hydrochloride | RxReference drug |
| Sensorcaine0.5% · injectable;injection | Bupivacaine Hydrochloride | RxReference drug |
| Sensorcaine0.75% · injectable;injection | Bupivacaine Hydrochloride | RxReference drug |
| Sensorcaine0.5%;0.0091MG/ML · injectable;injection | Bupivacaine Hydrochloride; Epinephrine Bitartrate | RxReference drug |
| Sensorcaine0.75%;0.0091MG/ML · injectable;injection | Bupivacaine Hydrochloride; Epinephrine Bitartrate | RxReference drug |
| Jul 19, 2022 | Supplement 50Labeling · Standard review | Approved | |
| Nov 2, 2018 | Supplement 49Labeling · Standard review | Approved | |
| Jan 29, 2016 | Supplement 40Manufacturing | Approved | None posted |
| Jul 10, 2015 | Supplement 45Labeling · Standard review | Approved | |
| Jul 10, 2015 | Supplement 44Labeling · Standard review | Approved | |
| May 17, 2010 | Supplement 36Labeling | Approved | None posted |
| Dec 23, 2002 | Supplement 33Manufacturing | Approved | None posted |
| Mar 8, 2002 | Supplement 32Manufacturing | Approved | None posted |
| Jun 8, 2001 | Supplement 31Manufacturing | Approved | None posted |
| Jun 1, 2001 | Supplement 30Labeling | Approved | None posted |
| Jul 30, 1999 | Supplement 29Manufacturing | Approved | None posted |
| Oct 14, 1997 | Supplement 24Manufacturing | Approved | None posted |
| Apr 14, 1997 | Supplement 28Manufacturing | Approved | None posted |
| May 31, 1996 | Supplement 27Manufacturing | Approved | None posted |
| Dec 27, 1994 | Supplement 23Manufacturing | Approved | None posted |
| Mar 10, 1993 | Supplement 20Manufacturing | Approved | None posted |
| Sep 11, 1992 | Supplement 21Manufacturing | Approved | None posted |
| May 8, 1992 | Supplement 19Manufacturing | Approved | None posted |
| Nov 8, 1991 | Supplement 18Manufacturing | Approved | None posted |
| Aug 27, 1991 | Supplement 16Labeling | Approved | None posted |
| Aug 27, 1991 | Supplement 12Labeling | Approved | None posted |
| Oct 27, 1989 | Supplement 13Manufacturing | Approved | None posted |
| Aug 1, 1989 | Supplement 15Manufacturing | Approved | None posted |
| Aug 1, 1989 | Supplement 14Manufacturing | Approved | None posted |
| May 11, 1988 | Supplement 11Labeling | Approved | None posted |
| Sep 24, 1987 | Supplement 9Manufacturing | Approved | None posted |
| Dec 30, 1981 | Original application | Approved | None posted |
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
