APPLICATION
ANDA070585
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-03
LATEST ACTION
2021-07-06
ROUTE
EPIDURAL, RETROBULBAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BUPIVACAINE HYDROCHLORIDEPrescription
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · INJECTION
Approval history
2021-07-06Labeling · Supplement 41 · standardAP
2020-12-09Labeling · Supplement 40 · standardAP
2020-12-09Labeling · Supplement 30 · standardAP
2015-08-18Labeling · Supplement 28 · standardAP
2010-04-07Labeling · Supplement 25AP
2005-01-27Labeling · Supplement 18AP
2002-10-25Manufacturing (CMC) · Supplement 17AP
2001-03-22Manufacturing (CMC) · Supplement 15AP
2001-03-22Manufacturing (CMC) · Supplement 16AP
2000-01-07Labeling · Supplement 13AP
2000-01-07Manufacturing (CMC) · Supplement 12AP
1999-11-02Labeling · Supplement 14AP
1996-10-22Manufacturing (CMC) · Supplement 8AP
1996-10-03Manufacturing (CMC) · Supplement 9AP
1995-09-22Manufacturing (CMC) · Supplement 5AP
1990-09-25Labeling · Supplement 4AP
1990-05-07Labeling · Supplement 3AP
1989-08-23Labeling · 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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