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FDA NDA · NDA009435
NESACAINE
chloroprocaine hydrochloride
Sponsor: FRESENIUS KABI USA
APPLICATION
NDA009435
TYPE
NDA
ORIGINAL APPROVAL
1955-03-11
LATEST ACTION
2018-11-02
ROUTE
INFILTRATION, PERINEURAL, EPIDURAL, INTRACAUDAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
NESACAINE-MPF · ReferencePrescription
CHLOROPROCAINE HYDROCHLORIDE 3% · INJECTABLE · INJECTION
NESACAINE-MPFDiscontinued
CHLOROPROCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
NESACAINE · ReferenceDiscontinued
CHLOROPROCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
NESACAINE-MPF · ReferencePrescription
CHLOROPROCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
NESACAINE-MPFDiscontinued
CHLOROPROCAINE HYDROCHLORIDE 3% · INJECTABLE · INJECTION
NESACAINE · ReferencePrescription
CHLOROPROCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
2013-02-16Manufacturing (CMC) · Supplement 40 · priorityAP
2002-02-15Manufacturing (CMC) · Supplement 33 · priorityAP
2000-11-10Labeling · Supplement 32 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 31 · priorityAP
1996-05-02Manufacturing (CMC) · Supplement 30 · priorityAP
1995-04-05Manufacturing (CMC) · Supplement 29 · priorityAP
1993-04-13Manufacturing (CMC) · Supplement 28 · priorityAP
1990-08-27Manufacturing (CMC) · Supplement 27 · priorityAP
1990-03-05Manufacturing (CMC) · Supplement 26 · priorityAP
1988-08-26Labeling · Supplement 25AP
1987-07-30Labeling · Supplement 24AP
1987-07-30Manufacturing (CMC) · Supplement 22 · priorityAP
1987-07-30Labeling · Supplement 23AP
1986-11-14Labeling · Supplement 20AP
1986-08-06Manufacturing (CMC) · Supplement 21 · priorityAP
1985-07-16Labeling · Supplement 16AP
1985-07-16Manufacturing (CMC) · Supplement 14 · priorityAP
1985-07-16Manufacturing (CMC) · Supplement 15 · priorityAP
1982-02-12Manufacturing (CMC) · Supplement 18 · priorityAP
1982-02-12Manufacturing (CMC) · Supplement 17 · priorityAP
1981-02-23Labeling · Supplement 13AP
1981-02-23Manufacturing (CMC) · Supplement 12 · priorityAP
1980-11-06Labeling · Supplement 8AP
1979-06-13Manufacturing (CMC) · Supplement 10 · priorityAP
1979-02-27Manufacturing (CMC) · Supplement 9 · priorityAP
1976-03-16Labeling · Supplement 4AP
1976-03-16Labeling · Supplement 5AP
1974-11-15Manufacturing (CMC) · Supplement 7 · priorityAP
1955-03-11Type 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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