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FDA NDA · NDA021384

DURANEST

Sponsor: DENTSPLY PHARM

APPLICATION
NDA021384
TYPE
NDA
ORIGINAL APPROVAL
1976-08-30
LATEST ACTION
1976-08-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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0.005MG/ML, ETIDOCAINE HYDROCHLORIDE 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

1976-08-30OriginalAP
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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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