← FDA DRUG APPROVALS

FDA NDA · NDA022046

BUPIVACAINE HYDROCHLORIDE

Sponsor: HOSPIRA

APPLICATION
NDA022046
TYPE
NDA
ORIGINAL APPROVAL
1983-07-13
LATEST ACTION
2018-11-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

BUPIVACAINE HYDROCHLORIDE · ReferencePrescription
BUPIVACAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE · ReferenceDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.5%, EPINEPHRINE BITARTRATE 0.0091MG/ML · INJECTABLE · INJECTION

Approval history

2018-11-02Labeling · Supplement 9 · standard — Label ↗AP
2013-07-30Manufacturing (CMC) · Supplement 5 · standardAP
2012-01-30Labeling · Supplement 4 · unknown — Label ↗AP
2006-08-31Labeling · Supplement 1 · standard — Letter ↗AP
1983-07-13UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →