← FDA DRUG APPROVALS

FDA ANDA · ANDA070552

SENSORCAINE MPF

bupivacaine hydrochloride

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA070552
TYPE
ANDA
ORIGINAL APPROVAL
1986-05-21
LATEST ACTION
2022-11-02
ROUTE
EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SENSORCAINEPrescription
BUPIVACAINE HYDROCHLORIDE 0.25% · INJECTABLE · INJECTION

Approval history

2022-11-02Labeling · Supplement 30 · standardAP
2015-09-01Labeling · Supplement 23 · standardAP
2010-05-17Labeling · Supplement 18AP
2002-03-08Manufacturing (CMC) · Supplement 16AP
2001-06-08Manufacturing (CMC) · Supplement 15AP
2001-05-21Labeling · Supplement 13AP
2000-09-07Manufacturing (CMC) · Supplement 14AP
1996-09-27Manufacturing (CMC) · Supplement 12AP
1996-05-31Manufacturing (CMC) · Supplement 11AP
1993-03-10Manufacturing (CMC) · Supplement 7AP
1992-09-11Manufacturing (CMC) · Supplement 8AP
1992-05-12Manufacturing (CMC) · Supplement 6AP
1991-09-03Manufacturing (CMC) · Supplement 2AP
1991-09-03Labeling · Supplement 1AP
1990-12-18Manufacturing (CMC) · Supplement 4AP
1989-09-12Labeling · Supplement 3AP
1986-05-21OriginalAP
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 →