Bupivacaine Hydrochloride

NDA 18053, held by Hospira. Bupivacaine Hydrochloride.

As of Nov 14, 2026, NDA 18053 (Bupivacaine Hydrochloride), held by Hospira, was first approved by FDA on Apr 17, 1978, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 17, 1978
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Apr 17, 1978	Original application	Approved	None posted

Products

3 strengths and forms


Bupivacaine Hydrochloride0.5% · injectable;injection	Bupivacaine Hydrochloride	Discontinued
Bupivacaine Hydrochloride0.25% · injectable;injection	Bupivacaine Hydrochloride	Discontinued
Bupivacaine Hydrochloride0.75% · injectable;injection	Bupivacaine Hydrochloride	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Mar 9, 2021	Supplement 61Labeling · Standard review	Approved	Label Letter
Nov 2, 2018	Supplement 60Labeling · Standard review	Approved	Letter Label
Jan 11, 2016	Supplement 57Manufacturing	Approved	None posted
Jul 10, 2015	Supplement 55Labeling · Standard review	Approved	Label Letter
May 6, 2014	Supplement 56Manufacturing	Approved	None posted
Apr 7, 2010	Supplement 52Labeling	Approved	None posted
Aug 29, 2002	Supplement 44Manufacturing	Approved	None posted
Nov 2, 1999	Supplement 43Labeling	Approved	None posted
Apr 7, 1999	Supplement 42Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 40Manufacturing	Approved	None posted
Nov 4, 1996	Supplement 38Manufacturing	Approved	None posted
Nov 4, 1996	Supplement 39Manufacturing	Approved	None posted
Jan 29, 1992	Supplement 35Manufacturing	Approved	None posted
Dec 11, 1991	Supplement 36Labeling	Approved	None posted
Feb 15, 1991	Supplement 33Labeling	Approved	None posted
May 4, 1990	Supplement 34Labeling	Approved	None posted
Apr 7, 1988	Supplement 31Manufacturing	Approved	None posted
Apr 17, 1978	Original application	Approved	None posted

Identifiers

Application: NDA 18053
Drugs@FDA: Overview at FDA
Company: Hospira

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