← FDA DRUG APPROVALS

FDA NDA · NDA018304

SENSORCAINE MPF

bupivacaine hydrochloride and epinephrine bitartrate

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA018304
TYPE
NDA
ORIGINAL APPROVAL
1981-12-30
LATEST ACTION
2022-07-19
ROUTE
EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL, RETROBULBAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SENSORCAINE · ReferencePrescription
BUPIVACAINE HYDROCHLORIDE 0.75%, EPINEPHRINE BITARTRATE 0.0091MG/ML · INJECTABLE · INJECTION
SENSORCAINE · ReferencePrescription
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · INJECTION
SENSORCAINE · ReferencePrescription
BUPIVACAINE HYDROCHLORIDE 0.25% · INJECTABLE · INJECTION
SENSORCAINE · ReferencePrescription
BUPIVACAINE HYDROCHLORIDE 0.5%, EPINEPHRINE BITARTRATE 0.0091MG/ML · INJECTABLE · INJECTION
SENSORCAINE · ReferencePrescription
BUPIVACAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION

Approval history

2022-07-19Labeling · Supplement 50 · standard — Letter ↗AP
2018-11-02Labeling · Supplement 49 · standard — Label ↗AP
2016-01-29Manufacturing (CMC) · Supplement 40AP
2015-07-10Labeling · Supplement 44 · standard — Letter ↗AP
2015-07-10Labeling · Supplement 45 · standard — Label ↗AP
2010-05-17Labeling · Supplement 36AP
2002-12-23Manufacturing (CMC) · Supplement 33AP
2002-03-08Manufacturing (CMC) · Supplement 32AP
2001-06-08Manufacturing (CMC) · Supplement 31AP
2001-06-01Labeling · Supplement 30AP
1999-07-30Manufacturing (CMC) · Supplement 29AP
1997-10-14Manufacturing (CMC) · Supplement 24AP
1997-04-14Manufacturing (CMC) · Supplement 28AP
1996-05-31Manufacturing (CMC) · Supplement 27AP
1994-12-27Manufacturing (CMC) · Supplement 23AP
1993-03-10Manufacturing (CMC) · Supplement 20AP
1992-09-11Manufacturing (CMC) · Supplement 21AP
1992-05-08Manufacturing (CMC) · Supplement 19AP
1991-11-08Manufacturing (CMC) · Supplement 18AP
1991-08-27Labeling · Supplement 16AP
1991-08-27Labeling · Supplement 12AP
1989-10-27Manufacturing (CMC) · Supplement 13AP
1989-08-01Manufacturing (CMC) · Supplement 14AP
1989-08-01Manufacturing (CMC) · Supplement 15AP
1988-05-11Labeling · Supplement 11AP
1987-09-24Manufacturing (CMC) · Supplement 9AP
1981-12-30OriginalAP
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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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