APPLICATION
NDA017751
TYPE
NDA
ORIGINAL APPROVAL
1976-08-30
LATEST ACTION
1999-03-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DURANEST · ReferenceDiscontinued
EPINEPHRINE BITARTRATE 0.005MG/ML, ETIDOCAINE HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DURANEST · ReferenceDiscontinued
EPINEPHRINE 0.005MG/ML, ETIDOCAINE HYDROCHLORIDE 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DURANEST · ReferenceDiscontinued
EPINEPHRINE BITARTRATE 0.005MG/ML, ETIDOCAINE HYDROCHLORIDE 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DURANEST · ReferenceDiscontinued
ETIDOCAINE HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DURANEST · ReferenceDiscontinued
ETIDOCAINE HYDROCHLORIDE 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1999-03-02Labeling · Supplement 13 · standardAP
1999-03-02Labeling · Supplement 11 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 12 · standardAP
1990-10-04Manufacturing (CMC) · Supplement 10 · standardAP
1987-04-08Labeling · Supplement 9 · standardAP
1987-01-29Labeling · Supplement 4 · standardAP
1986-03-06Labeling · Supplement 8 · standardAP
1985-08-07Labeling · Supplement 7 · standardAP
1985-08-07Manufacturing (CMC) · Supplement 6 · standardAP
1982-07-13Labeling · Supplement 3 · standardAP
1982-07-13Manufacturing (CMC) · Supplement 2 · standardAP
1982-06-28Manufacturing (CMC) · Supplement 5 · standardAP
1979-08-29Labeling · Supplement 1 · standardAP
1976-08-30Type 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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