APPLICATION
ANDA071202
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-15
LATEST ACTION
2012-12-11
ROUTE
SPINAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
SENSORCAINEDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · SPINAL
Approval history
2012-12-11Labeling · Supplement 16 · standardAP
2012-06-30Manufacturing (CMC) · Supplement 14AP
2010-06-14Labeling · Supplement 12AP
2005-07-21Labeling · Supplement 10AP
2002-12-23Manufacturing (CMC) · Supplement 9AP
1997-04-14Manufacturing (CMC) · Supplement 8AP
1996-06-26Manufacturing (CMC) · Supplement 3AP
1996-05-31Manufacturing (CMC) · Supplement 7AP
1996-04-17Manufacturing (CMC) · Supplement 5AP
1995-08-29Manufacturing (CMC) · Supplement 4AP
1992-09-11Manufacturing (CMC) · Supplement 2AP
1991-09-03Labeling · Supplement 1AP
1987-04-15OriginalAP
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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