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Generated: November 14, 2018

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Details for New Drug Application (NDA): 018461

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NDA 018461 describes LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun and Baxter Hlthcare and is included in three NDAs. It is available from two suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 018461
Pharmacology for NDA: 018461
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 018461
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER lidocaine hydrochloride INJECTABLE;INJECTION 018461 NDA Baxter Healthcare Corporation 0338-0409 0338-0409-02 24 BAG in 1 CARTON (0338-0409-02) > 250 mL in 1 BAG
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER lidocaine hydrochloride INJECTABLE;INJECTION 018461 NDA Baxter Healthcare Corporation 0338-0409 0338-0409-02 24 BAG in 1 CARTON (0338-0409-02) > 250 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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