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Generated: January 18, 2019

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Details for New Drug Application (NDA): 083914

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NDA 083914 describes LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, which is a drug marketed by Hospira and is included in one NDA. It is available from one supplier. Additional details are available on the LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5% profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5% is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 083914
Ingredient:lidocaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 083914
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 083914
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5% lidocaine hydrochloride INJECTABLE;SPINAL 083914 ANDA Hospira, Inc. 0409-4712 0409-4712-01 5 CELLO PACK in 1 PACKAGE (0409-4712-01) > 5 AMPULE in 1 CELLO PACK (0409-4712-25) > 2 mL in 1 AMPULE (0409-4712-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SPINALStrength5%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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