APPLICATION
NDA008592
TYPE
NDA
ORIGINAL APPROVAL
1952-09-19
LATEST ACTION
2001-09-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRINDiscontinued
LEVONORDEFRIN 0.05MG/ML, PROCAINE HYDROCHLORIDE 2%, PROPOXYCAINE HYDROCHLORIDE 0.4% · INJECTABLE · INJECTION
RAVOCAINE AND NOVOCAIN W/ LEVOPHEDDiscontinued
NOREPINEPHRINE BITARTRATE EQ 0.033MG BASE/ML, PROCAINE HYDROCHLORIDE 2%, PROPOXYCAINE HYDROCHLORIDE 0.4% · INJECTABLE · INJECTION
Approval history
2001-09-17Labeling · Supplement 5AP
2001-09-17Labeling · Supplement 8AP
2001-09-17Labeling · Supplement 6AP
2001-09-17Labeling · Supplement 2AP
2001-09-17Labeling · Supplement 11AP
2001-09-17Labeling · Supplement 7AP
1991-08-08Labeling · Supplement 21AP
1982-02-16Labeling · Supplement 14AP
1978-12-27Labeling · Supplement 9AP
1975-01-03Labeling · Supplement 3AP
1952-09-19Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standardAP
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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