Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021384
Company: DENTSPLY PHARM
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ETIDOCAINE HYDROCHLORIDE 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
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

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