Details for New Drug Application (NDA): 079235
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NDA 079235 describes PRILOCAINE HYDROCHLORIDE, which is a drug marketed by Septodont Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the PRILOCAINE HYDROCHLORIDE profile page.
The generic ingredient in PRILOCAINE HYDROCHLORIDE 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 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 079235
| Tradename: | PRILOCAINE HYDROCHLORIDE |
| Applicant: | Septodont Inc |
| Ingredient: | prilocaine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079235
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 079235
Suppliers and Packaging for NDA: 079235
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRILOCAINE HYDROCHLORIDE | prilocaine hydrochloride | INJECTABLE;INJECTION | 079235 | ANDA | Dentsply Pharmaceutical Inc. | 66312-630 | 66312-630-14 | 50 CARTRIDGE in 1 CARTON (66312-630-14) / 1.8 mL in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4% | ||||
| Approval Date: | Sep 29, 2010 | TE: | RLD: | No | |||||
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