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Generated: November 16, 2018

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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 seven suppliers. Additional details are available on the XYLOCAINE profile page.

The generic ingredient in XYLOCAINE is epinephrine; lidocaine hydrochloride. There are twenty 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:XYLOCAINE
Applicant:Oak Pharms
Ingredient:lidocaine hydrochloride
Patents:0
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 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) 76478-479 76478-479-05 1 TUBE in 1 CARTON (76478-479-05) > 5 mL in 1 TUBE
XYLOCAINE lidocaine hydrochloride JELLY;TOPICAL 008816 NDA Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) 76478-479 76478-479-30 1 TUBE in 1 CARTON (76478-479-30) > 30 mL in 1 TUBE

Profile 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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