Details for New Drug Application (NDA): 079235
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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 |
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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