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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 Oak Pharms, Astrazeneca, Fresenius Kabi Usa, and Dentsply Pharm, and is included in fourteen NDAs. It is available from eight suppliers. Additional details are available on the XYLOCAINE profile page.

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

Summary for NDA: 008816

Oak Pharms
lidocaine hydrochloride
Therapeutic Class:Anesthetics

Pharmacology for NDA: 008816

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 008816

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
lidocaine hydrochloride
JELLY;TOPICAL 008816 NDA APP Pharmaceuticals, LLC 63323-479 63323-479-05 10 TUBE in 1 CARTON (63323-479-05) > 5 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.