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FDA ANDA · ANDA084850

MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN

Sponsor: BELMORA LLC

APPLICATION
ANDA084850
TYPE
ANDA
ORIGINAL APPROVAL
1976-01-22
LATEST ACTION
1994-08-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

1994-08-10Labeling · Supplement 31AP
1993-12-22Labeling · Supplement 30AP
1993-08-25Labeling · Supplement 29AP
1993-03-24Labeling · Supplement 28AP
1989-10-31Labeling · Supplement 27AP
1988-08-04Manufacturing (CMC) · Supplement 25AP
1988-08-04Manufacturing (CMC) · Supplement 23AP
1987-04-03Manufacturing (CMC) · Supplement 21AP
1985-05-24Manufacturing (CMC) · Supplement 18AP
1985-05-24Manufacturing (CMC) · Supplement 17AP
1982-08-02Manufacturing (CMC) · Supplement 11AP
1976-01-22OriginalAP
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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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