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FDA NDA · NDA018692

MARCAINE SPINAL

bupivacaine hydrochloride in dextrose

Sponsor: HOSPIRA

APPLICATION
NDA018692
TYPE
NDA
ORIGINAL APPROVAL
1984-05-04
LATEST ACTION
2022-09-28
ROUTE
SUBARACHNOID, SPINAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MARCAINE · ReferencePrescription
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · SPINAL

Approval history

2022-09-28Labeling · Supplement 24 · standard — Letter ↗AP
2018-11-02Labeling · Supplement 20 · standard — Label ↗AP
2014-09-19Manufacturing (CMC) · Supplement 16 · standardAP
2012-01-30Labeling · Supplement 15 · standard — Label ↗AP
2010-02-19Labeling · Supplement 14 · 901 required — Label ↗AP
2003-06-12Labeling · Supplement 7 · standard — Letter ↗AP
2001-08-21Manufacturing (CMC) · Supplement 4 · standardAP
1999-03-09Labeling · Supplement 2AP
1999-03-09Labeling · Supplement 3 · standardAP
1987-06-26Manufacturing (CMC) · Supplement 1 · standardAP
1984-05-04Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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