Bupivacaine Hydrochloride And Epinephrine, Bupivacaine Hydrochloride

NDA 22046, held by Hospira. Bupivacaine Hydrochloride; Epinephrine Bitartrate, Bupivacaine Hydrochloride.

As of Nov 14, 2026, NDA 22046 (Bupivacaine Hydrochloride And Epinephrine, Bupivacaine Hydrochloride), held by Hospira, was first approved by FDA on Jul 13, 1983, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 13, 1983
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jul 13, 1983	Original application	Approved	None posted

Products

2 strengths and forms


Bupivacaine Hydrochloride And Epinephrine0.5%;0.0091MG/ML · injectable;injection	Bupivacaine Hydrochloride; Epinephrine Bitartrate	DiscontinuedReference drug
Bupivacaine Hydrochloride0.5% · injectable; injection	Bupivacaine Hydrochloride	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Nov 2, 2018	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 30, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 30, 2012	Supplement 4Labeling	Approved	Letter Label
Aug 31, 2006	Supplement 1Labeling · Standard review	Approved	Letter Label
Jul 13, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 22046
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