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FDA ANDA · ANDA084697

ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN

Sponsor: SEPTODONT

APPLICATION
ANDA084697
TYPE
ANDA
ORIGINAL APPROVAL
1976-02-06
LATEST ACTION
1999-08-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRINDiscontinued
LEVONORDEFRIN 0.05MG/ML, MEPIVACAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION

Approval history

1999-08-02Manufacturing (CMC) · Supplement 22AP
1994-04-13Manufacturing (CMC) · Supplement 18AP
1994-04-13Manufacturing (CMC) · Supplement 20AP
1993-04-19Labeling · Supplement 21AP
1993-01-26Manufacturing (CMC) · Supplement 19AP
1992-04-07Labeling · Supplement 17AP
1984-10-11Manufacturing (CMC) · Supplement 11AP
1984-09-12Manufacturing (CMC) · Supplement 14AP
1983-10-13Manufacturing (CMC) · Supplement 13AP
1982-08-11Manufacturing (CMC) · Supplement 6AP
1982-07-09Manufacturing (CMC) · Supplement 5AP
1982-07-09Manufacturing (CMC) · Supplement 4AP
1976-02-06OriginalAP
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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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