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FDA ANDA · ANDA070554

SENSORCAINE MPF

bupivacaine hydrochloride

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA070554
TYPE
ANDA
ORIGINAL APPROVAL
1986-05-21
LATEST ACTION
2022-11-02
ROUTE
EPIDURAL, RETROBULBAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SENSORCAINEPrescription
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · INJECTION

Approval history

2022-11-02Labeling · Supplement 37 · standardAP
2015-09-01Labeling · Supplement 28 · standardAP
2010-05-17Labeling · Supplement 21AP
2002-03-08Manufacturing (CMC) · Supplement 19AP
2001-06-08Manufacturing (CMC) · Supplement 18AP
2001-05-21Labeling · Supplement 17AP
1997-08-25Manufacturing (CMC) · Supplement 16AP
1996-06-26Manufacturing (CMC) · Supplement 13AP
1996-05-31Manufacturing (CMC) · Supplement 15AP
1993-03-10Manufacturing (CMC) · Supplement 10AP
1992-09-11Manufacturing (CMC) · Supplement 11AP
1992-05-12Manufacturing (CMC) · Supplement 9AP
1991-09-03Manufacturing (CMC) · Supplement 6AP
1991-09-03Labeling · Supplement 5AP
1990-12-18Manufacturing (CMC) · Supplement 7AP
1987-11-10Labeling · Supplement 4AP
1987-10-14Manufacturing (CMC) · Supplement 1AP
1987-10-14Labeling · Supplement 2AP
1987-10-14Manufacturing (CMC) · Supplement 3AP
1986-05-21OriginalAP
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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