APPLICATION
NDA019978
TYPE
NDA
ORIGINAL APPROVAL
1992-09-03
LATEST ACTION
1999-01-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUPIVACAINE HYDROCHLORIDE KITDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.114% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDE KITDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.23% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDE KITDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.075% · INJECTABLE · INJECTION
Approval history
1999-01-21Manufacturing (CMC) · Supplement 6 · standardAP
1998-10-23Manufacturing (CMC) · Supplement 5 · standardAP
1995-02-09Manufacturing (CMC) · Supplement 4 · standardAP
1994-05-26Labeling · Supplement 3 · standardAP
1993-02-26Manufacturing (CMC) · Supplement 1 · standardAP
1992-09-03Type 3 - New Dosage Form · Original · standardAP
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.
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