Details for New Drug Application (NDA): 078959
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NDA 078959 describes PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, which is a drug marketed by Septodont Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE profile page.
The generic ingredient in PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE is epinephrine bitartrate; prilocaine hydrochloride. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate; prilocaine hydrochloride profile page.
The generic ingredient in PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE is epinephrine bitartrate; prilocaine hydrochloride. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate; prilocaine hydrochloride profile page.
Summary for 078959
| Tradename: | PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE |
| Applicant: | Septodont Inc |
| Ingredient: | epinephrine bitartrate; prilocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078959
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 078959
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | epinephrine bitartrate; prilocaine hydrochloride | INJECTABLE;INJECTION | 078959 | ANDA | Dentsply Pharmaceutical Inc. | 66312-580 | 66312-580-16 | 50 CARTRIDGE in 1 CARTON (66312-580-16) / 1.8 mL in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.005MG/ML;4% | ||||
| Approval Date: | Aug 30, 2011 | TE: | AP | RLD: | No | ||||
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