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FDA NDA · NDA020997

CHIROCAINE

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APPLICATION
NDA020997
TYPE
NDA
ORIGINAL APPROVAL
1999-08-05
LATEST ACTION
2002-08-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CHIROCAINE · ReferenceDiscontinued
LEVOBUPIVACAINE HYDROCHLORIDE EQ 7.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CHIROCAINE · ReferenceDiscontinued
LEVOBUPIVACAINE HYDROCHLORIDE EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CHIROCAINE · ReferenceDiscontinued
LEVOBUPIVACAINE HYDROCHLORIDE EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2002-08-30Manufacturing (CMC) · Supplement 6 · standardAP
1999-12-02Labeling · Supplement 1 · standardAP
1999-08-05Type 2 - New Active Ingredient · Original · standard — Letter ↗AP
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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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