APPLICATION
ANDA070584
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-17
LATEST ACTION
2021-07-06
ROUTE
EPIDURAL, INTRACAUDAL, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BUPIVACAINE HYDROCHLORIDEPrescription
BUPIVACAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION
Approval history
2021-07-06Labeling · Supplement 40 · standardAP
2020-12-09Labeling · Supplement 39 · standardAP
2020-12-09Labeling · Supplement 29 · standardAP
2015-08-18Labeling · Supplement 27 · standardAP
2010-04-07Labeling · Supplement 24AP
2002-10-25Manufacturing (CMC) · Supplement 17AP
2001-03-22Manufacturing (CMC) · Supplement 16AP
2001-03-22Manufacturing (CMC) · Supplement 15AP
2000-01-07Manufacturing (CMC) · Supplement 12AP
2000-01-07Labeling · Supplement 13AP
1999-11-02Labeling · Supplement 14AP
1996-10-22Manufacturing (CMC) · Supplement 8AP
1996-10-03Manufacturing (CMC) · Supplement 9AP
1995-07-07Manufacturing (CMC) · Supplement 5AP
1995-07-06Manufacturing (CMC) · Supplement 4AP
1990-09-25Labeling · Supplement 3AP
1990-05-07Labeling · Supplement 2AP
1989-08-23Labeling · Supplement 1AP
1987-02-17OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.