APPLICATION
NDA014763
TYPE
NDA
ORIGINAL APPROVAL
1965-11-18
LATEST ACTION
2000-12-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CITANEST PLAIN · ReferenceDiscontinued
PRILOCAINE HYDROCHLORIDE 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CITANEST · ReferenceDiscontinued
PRILOCAINE HYDROCHLORIDE 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CITANEST · ReferenceDiscontinued
PRILOCAINE HYDROCHLORIDE 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CITANEST FORTEDiscontinued
EPINEPHRINE BITARTRATE 0.005MG/ML, PRILOCAINE HYDROCHLORIDE 4% · INJECTABLE · INJECTION
CITANEST · ReferenceDiscontinued
PRILOCAINE HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2000-12-01Manufacturing (CMC) · Supplement 36 · priorityAP
1997-05-09Labeling · Supplement 34 · priorityAP
1996-05-31Manufacturing (CMC) · Supplement 35 · priorityAP
1987-03-11Labeling · Supplement 26 · priorityAP
1986-08-29Labeling · Supplement 24 · priorityAP
1986-03-21Labeling · Supplement 25 · priorityAP
1985-03-24Labeling · Supplement 21 · priorityAP
1985-03-22Labeling · Supplement 22 · priorityAP
1982-07-27Manufacturing (CMC) · Supplement 18 · priorityAP
1982-07-27Labeling · Supplement 19 · priorityAP
1982-06-28Manufacturing (CMC) · Supplement 23 · priorityAP
1981-08-31Manufacturing (CMC) · Supplement 17 · priorityAP
1981-08-31Labeling · Supplement 20 · priorityAP
1981-05-08Manufacturing (CMC) · Supplement 16 · priorityAP
1979-08-29Labeling · Supplement 15 · priorityAP
1979-04-09Manufacturing (CMC) · Supplement 13 · priorityAP
1979-04-04Labeling · Supplement 14 · priorityAP
1976-03-03Labeling · Supplement 11 · priorityAP
1976-03-03Manufacturing (CMC) · Supplement 10 · priorityAP
1965-11-18Type 1 - New Molecular Entity · Original · priorityAP
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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