APPLICATION
ANDA070586
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-03
LATEST ACTION
2021-07-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUPIVACAINE HYDROCHLORIDEDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.25% · INJECTABLE · INJECTION
Approval history
2021-07-06Labeling · Supplement 24 · standardAP
2020-12-09Labeling · Supplement 20 · standardAP
2020-12-09Labeling · Supplement 23 · standardAP
2015-08-18Labeling · Supplement 18 · standardAP
2010-04-27Labeling · Supplement 15AP
1999-11-02Labeling · Supplement 10AP
1996-10-03Manufacturing (CMC) · Supplement 7AP
1996-06-18Manufacturing (CMC) · Supplement 4AP
1990-09-25Labeling · Supplement 3AP
1990-06-22Labeling · Supplement 2AP
1990-05-07Labeling · Supplement 1AP
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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