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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016801

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NDA 016801 describes XYLOCAINE PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. Additional details are available on the XYLOCAINE PRESERVATIVE FREE profile page.

The generic ingredient in XYLOCAINE PRESERVATIVE FREE is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 016801
Tradename:XYLOCAINE PRESERVATIVE FREE
Applicant:Fresenius Kabi Usa
Ingredient:lidocaine hydrochloride
Patents:0
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 016801
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 016801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XYLOCAINE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 016801 NDA APP Pharmaceuticals, LLC 63323-498 63323-498-89 10 AMPULE in 1 BOX (63323-498-89) > 5 mL in 1 AMPULE

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Chubb
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