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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 008816

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NDA 008816 describes XYLOCAINE, which is a drug marketed by Astrazeneca, Fresenius Kabi Usa, Oak Pharms, and Dentsply Pharm, and is included in fourteen NDAs. It is available from nine suppliers. Additional details are available on the XYLOCAINE profile page.

The generic ingredient in XYLOCAINE is epinephrine; lidocaine hydrochloride. There are nineteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 008816

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 008816

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 008816

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XYLOCAINE lidocaine hydrochloride JELLY;TOPICAL 008816 NDA Cardinal Health 55154-9607 55154-9607-5 5 TUBE in 1 BAG (55154-9607-5) > 5 mL in 1 TUBE
XYLOCAINE lidocaine hydrochloride JELLY;TOPICAL 008816 NDA APP Pharmaceuticals, LLC 63323-479 63323-479-30 1 TUBE in 1 CARTON (63323-479-30) > 30 mL in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:JELLY;TOPICALStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes


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Serving leading biopharmaceutical companies globally:

Dow
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