Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021384
Company: DENTSPLY PHARM

Products on NDA 021384

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DURANEST	EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE	0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021384

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/1976	ORIG-1	Approval				Label is not available on this site.