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Cerilliant
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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 009435

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NDA 009435 describes NESACAINE-MPF, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from two suppliers. Additional details are available on the NESACAINE-MPF profile page.

The generic ingredient in NESACAINE-MPF is chloroprocaine hydrochloride. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.
Summary for 009435
Tradename:NESACAINE-MPF
Applicant:Fresenius Kabi Usa
Ingredient:chloroprocaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 009435
Ingredient-typeEsters
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 009435
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NESACAINE chloroprocaine hydrochloride INJECTABLE;INJECTION 009435 NDA General Injectables & Vaccines, Inc 52584-475 N 52584-475-37
NESACAINE chloroprocaine hydrochloride INJECTABLE;INJECTION 009435 NDA General Injectables & Vaccines, Inc 52584-476 N 52584-476-37

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Cantor Fitzgerald
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