APPLICATION
NDA016636
TYPE
NDA
ORIGINAL APPROVAL
1971-04-13
LATEST ACTION
2002-10-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NARCAN · ReferenceDiscontinued
NALOXONE HYDROCHLORIDE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
NARCAN · ReferenceDiscontinued
NALOXONE HYDROCHLORIDE 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
NARCAN · ReferenceDiscontinued
NALOXONE HYDROCHLORIDE 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-10-25Manufacturing (CMC) · Supplement 57 · priorityAP
2002-04-16Manufacturing (CMC) · Supplement 55 · priorityAP
2002-01-15Manufacturing (CMC) · Supplement 56 · priorityAP
1996-09-06Manufacturing (CMC) · Supplement 53 · priorityAP
1995-06-15Manufacturing (CMC) · Supplement 50 · priorityAP
1995-03-20Manufacturing (CMC) · Supplement 51 · priorityAP
1992-05-29Efficacy · Supplement 31 · priorityAP
1987-12-07Manufacturing (CMC) · Supplement 49 · priorityAP
1987-10-20Manufacturing (CMC) · Supplement 48 · priorityAP
1987-02-26Manufacturing (CMC) · Supplement 47 · priorityAP
1986-06-04Labeling · Supplement 46 · priorityAP
1986-06-04Manufacturing (CMC) · Supplement 42 · priorityAP
1986-06-04Manufacturing (CMC) · Supplement 43 · priorityAP
1986-06-04Manufacturing (CMC) · Supplement 41 · priorityAP
1985-07-23Labeling · Supplement 34 · priorityAP
1984-10-15Manufacturing (CMC) · Supplement 35 · priorityAP
1984-09-25Manufacturing (CMC) · Supplement 36 · priorityAP
1984-09-17Manufacturing (CMC) · Supplement 38 · priorityAP
1984-09-17Manufacturing (CMC) · Supplement 39 · priorityAP
1983-11-17Manufacturing (CMC) · Supplement 32 · priorityAP
1983-11-17Manufacturing (CMC) · Supplement 33 · priorityAP
1983-06-23Manufacturing (CMC) · Supplement 30 · priorityAP
1982-07-23Labeling · Supplement 27 · priorityAP
1982-06-14Manufacturing (CMC) · Supplement 28 · priorityAP
1982-05-19Manufacturing (CMC) · Supplement 26 · priorityAP
1981-09-30Labeling · Supplement 22 · priorityAP
1981-06-23Manufacturing (CMC) · Supplement 20 · priorityAP
1981-05-14Manufacturing (CMC) · Supplement 24 · priorityAP
1981-05-14Manufacturing (CMC) · Supplement 23 · priorityAP
1981-04-01Manufacturing (CMC) · Supplement 21 · priorityAP
1980-06-17Manufacturing (CMC) · Supplement 19 · priorityAP
1979-11-30Manufacturing (CMC) · Supplement 18 · priorityAP
1979-03-23Labeling · Supplement 17 · priorityAP
1978-10-20Manufacturing (CMC) · Supplement 16 · priorityAP
1976-04-08Labeling · Supplement 14 · priorityAP
1976-04-06Labeling · Supplement 15 · priorityAP
1975-09-24Labeling · Supplement 13 · priorityAP
1975-06-06Labeling · Supplement 11 · 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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