← FDA DRUG APPROVALS

FDA ANDA · ANDA071166

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Sponsor: HOSPIRA

APPLICATION
ANDA071166
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-16
LATEST ACTION
1999-11-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.25%, EPINEPHRINE 0.005MG/ML · INJECTABLE · INJECTION

Approval history

1999-11-22Labeling · Supplement 7AP
1991-02-21Manufacturing (CMC) · Supplement 1AP
1990-10-03Labeling · Supplement 5AP
1990-05-04Labeling · Supplement 4AP
1988-06-16OriginalAP
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 →