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Generated: November 14, 2018

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Details for New Drug Application (NDA): 089407

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NDA 089407 describes POLOCAINE, which is a drug marketed by Dentsply Pharm and Fresenius Kabi Usa and is included in seven NDAs. It is available from one supplier. Additional details are available on the POLOCAINE profile page.

The generic ingredient in POLOCAINE is levonordefrin; mepivacaine hydrochloride. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the levonordefrin; mepivacaine hydrochloride profile page.
Summary for 089407
Tradename:POLOCAINE
Applicant:Fresenius Kabi Usa
Ingredient:mepivacaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089407
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 089407
Suppliers and Packaging for NDA: 089407
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLOCAINE mepivacaine hydrochloride INJECTABLE;INJECTION 089407 ANDA Fresenius Kabi USA, LLC 63323-283 63323-283-57 25 VIAL, MULTI-DOSE in 1 TRAY (63323-283-57) > 50 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Dec 1, 1986TE:APRLD:No

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