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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 089409

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NDA 089409 describes POLOCAINE-MPF, which is a drug marketed by Fresenius Kabi Usa and is included in three NDAs. It is available from two suppliers. Additional details are available on the POLOCAINE-MPF profile page.

The generic ingredient in POLOCAINE-MPF is mepivacaine hydrochloride. There are six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the mepivacaine hydrochloride profile page.
Summary for 089409
Applicant:Fresenius Kabi Usa
Ingredient:mepivacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 089409
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 089409
Suppliers and Packaging for NDA: 089409
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLOCAINE-MPF mepivacaine hydrochloride INJECTABLE;INJECTION 089409 ANDA Fresenius Kabi USA, LLC 63323-294 63323-294-27 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-294-27) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-294-01)

Profile for product number 001

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

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