APPLICATION
NDA016820
TYPE
NDA
ORIGINAL APPROVAL
1974-03-12
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
EMETE-CONDiscontinued
BENZQUINAMIDE HYDROCHLORIDE EQ 50MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 4AP
1990-01-16Manufacturing (CMC) · Supplement 15 · standardAP
1989-04-19Manufacturing (CMC) · Supplement 14 · standardAP
1986-11-25Manufacturing (CMC) · Supplement 13 · standardAP
1983-06-23Manufacturing (CMC) · Supplement 11 · standardAP
1981-04-16Manufacturing (CMC) · Supplement 10 · standardAP
1979-10-02Manufacturing (CMC) · Supplement 9 · standardAP
1979-10-02Manufacturing (CMC) · Supplement 7 · standardAP
1979-10-02Manufacturing (CMC) · Supplement 8 · standardAP
1977-12-14Manufacturing (CMC) · Supplement 5 · standardAP
1977-12-14Labeling · Supplement 6AP
1974-08-14Manufacturing (CMC) · Supplement 3 · standardAP
1974-08-06Manufacturing (CMC) · Supplement 1 · standardAP
1974-05-21Manufacturing (CMC) · Supplement 2 · standardAP
1974-03-12Type 1 - New Molecular Entity · 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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