APPLICATION
NDA012250
TYPE
NDA
ORIGINAL APPROVAL
1960-05-17
LATEST ACTION
2023-12-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CARBOCAINE · ReferenceDiscontinued
MEPIVACAINE HYDROCHLORIDE 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CARBOCAINE · ReferenceDiscontinued
MEPIVACAINE HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CARBOCAINE · ReferenceDiscontinued
MEPIVACAINE HYDROCHLORIDE 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2001-01-31Manufacturing (CMC) · Supplement 23 · priorityAP
1999-04-27Labeling · Supplement 19AP
1999-03-11Labeling · Supplement 22 · standardAP
1991-05-21Manufacturing (CMC) · Supplement 20 · priorityAP
1987-01-29Labeling · Supplement 16AP
1985-03-15Manufacturing (CMC) · Supplement 18 · priorityAP
1984-03-30Manufacturing (CMC) · Supplement 17 · priorityAP
1981-08-21Manufacturing (CMC) · Supplement 15 · priorityAP
1980-10-03Manufacturing (CMC) · Supplement 14 · priorityAP
1979-06-26Labeling · Supplement 12AP
1978-06-15Manufacturing (CMC) · Supplement 13 · priorityAP
1976-10-06Manufacturing (CMC) · Supplement 10 · priorityAP
1975-10-28Labeling · Supplement 8AP
1974-04-15Labeling · Supplement 7AP
1960-05-17Type 3 - New Dosage Form · 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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