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Generated: April 22, 2019

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Details for New Drug Application (NDA): 089406

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NDA 089406 describes POLOCAINE-MPF, which is a drug marketed by Fresenius Kabi Usa and is included in three NDAs. It is available from one supplier. 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. Fourteen suppliers are listed for this compound. Additional details are available on the mepivacaine hydrochloride profile page.
Summary for 089406
Applicant:Fresenius Kabi Usa
Ingredient:mepivacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 089406
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 089406
Suppliers and Packaging for NDA: 089406
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLOCAINE-MPF mepivacaine hydrochloride INJECTABLE;INJECTION 089406 ANDA Fresenius Kabi USA, LLC 63323-260 63323-260-37 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-260-37) > 30 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

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

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