APPLICATION
ANDA070587
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-03
LATEST ACTION
2010-04-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUPIVACAINE HYDROCHLORIDEDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · INJECTION
Approval history
2010-04-27Labeling · Supplement 18AP
1999-11-02Labeling · Supplement 13AP
1996-10-03Manufacturing (CMC) · Supplement 11AP
1996-06-26Manufacturing (CMC) · Supplement 5AP
1995-02-23Manufacturing (CMC) · Supplement 6AP
1990-10-03Labeling · Supplement 4AP
1990-06-22Labeling · Supplement 3AP
1990-05-07Labeling · Supplement 2AP
1987-03-03OriginalAP
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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