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Last Updated: July 14, 2020

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Details for New Drug Application (NDA): 089410

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NDA 089410 describes POLOCAINE, which is a drug marketed by Dentsply Pharm and Fresenius Kabi Usa and is included in seven NDAs. It is available from two suppliers. 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. One supplier is listed for this compound. Additional details are available on the levonordefrin; mepivacaine hydrochloride profile page.
Summary for 089410
Applicant:Fresenius Kabi Usa
Ingredient:mepivacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 089410
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 089410
Suppliers and Packaging for NDA: 089410
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLOCAINE mepivacaine hydrochloride INJECTABLE;INJECTION 089410 ANDA A-S Medication Solutions 50090-4408 50090-4408-0 1 VIAL, MULTI-DOSE in 1 BAG (50090-4408-0) > 50 mL in 1 VIAL, MULTI-DOSE
POLOCAINE mepivacaine hydrochloride INJECTABLE;INJECTION 089410 ANDA Fresenius Kabi USA, LLC 63323-296 63323-296-57 25 VIAL, MULTI-DOSE in 1 TRAY (63323-296-57) > 50 mL in 1 VIAL, MULTI-DOSE (63323-296-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Dec 1, 1986TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Harvard Business School

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