Details for New Drug Application (NDA): 021384
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NDA 021384 describes DURANEST, which is a drug marketed by Astrazeneca and Dentsply Pharm and is included in two NDAs. Additional details are available on the DURANEST profile page.
The generic ingredient in DURANEST is etidocaine hydrochloride. Additional details are available on the etidocaine hydrochloride profile page.
The generic ingredient in DURANEST is etidocaine hydrochloride. Additional details are available on the etidocaine hydrochloride profile page.
Summary for 021384
| Tradename: | DURANEST |
| Applicant: | Dentsply Pharm |
| Ingredient: | epinephrine bitartrate; etidocaine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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