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FDA ANDA · ANDA070967

SENSORCAINE

bupivacaine hydrochloride and epinephrine bitartrate

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA070967
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-13
LATEST ACTION
2022-11-02
ROUTE
INFILTRATION, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SENSORCAINEPrescription
BUPIVACAINE HYDROCHLORIDE 0.25%, EPINEPHRINE BITARTRATE 0.0091MG/ML · INJECTABLE · INJECTION

Approval history

2022-11-02Labeling · Supplement 33 · standardAP
2015-09-01Labeling · Supplement 25 · standardAP
2010-05-19Labeling · Supplement 19AP
2002-03-08Manufacturing (CMC) · Supplement 16AP
2001-06-08Manufacturing (CMC) · Supplement 15AP
2001-05-21Labeling · Supplement 14AP
1997-08-25Manufacturing (CMC) · Supplement 13AP
1997-04-14Manufacturing (CMC) · Supplement 12AP
1996-05-31Manufacturing (CMC) · Supplement 11AP
1993-03-10Manufacturing (CMC) · Supplement 7AP
1992-09-11Manufacturing (CMC) · Supplement 8AP
1992-05-13Manufacturing (CMC) · Supplement 6AP
1991-12-03Manufacturing (CMC) · Supplement 3AP
1991-12-03Manufacturing (CMC) · Supplement 2AP
1991-08-27Labeling · Supplement 4AP
1987-11-10Labeling · Supplement 1AP
1987-10-13OriginalAP
VIEW ON DRUGS@FDA ↗

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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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