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FDA ANDA · ANDA070966

SENSORCAINE MPF

bupivacaine hydrochloride and epinephrine bitartrate

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA070966
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-13
LATEST ACTION
2022-11-02
ROUTE
EPIDURAL, INFILTRATION, INTRACAUDAL, 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 38 · standardAP
2015-09-01Labeling · Supplement 28 · standardAP
2010-05-19Labeling · Supplement 20AP
2002-03-08Manufacturing (CMC) · Supplement 17AP
2001-06-08Manufacturing (CMC) · Supplement 16AP
2001-05-21Labeling · Supplement 15AP
1997-08-25Manufacturing (CMC) · Supplement 14AP
1997-04-14Manufacturing (CMC) · Supplement 13AP
1996-05-31Manufacturing (CMC) · Supplement 12AP
1993-03-10Manufacturing (CMC) · Supplement 8AP
1992-09-11Manufacturing (CMC) · Supplement 9AP
1992-05-13Manufacturing (CMC) · Supplement 7AP
1991-12-03Manufacturing (CMC) · Supplement 3AP
1991-12-03Manufacturing (CMC) · Supplement 4AP
1991-09-12Manufacturing (CMC) · Supplement 5AP
1991-09-12Labeling · Supplement 2AP
1987-10-13OriginalAP
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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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