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Details for New Drug Application (NDA): 019830

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NDA 019830 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. Fifty-two suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.

Summary for NDA: 019830

Tradename:
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:
B Braun
Ingredient:
lidocaine hydrochloride
Patents:0
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 019830

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 019830

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
lidocaine hydrochloride
INJECTABLE;INJECTION 019830 NDA B. Braun Medical Inc. 0264-9594 0264-9594-10 24 CONTAINER in 1 CASE (0264-9594-10) > 500 mL in 1 CONTAINER
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
lidocaine hydrochloride
INJECTABLE;INJECTION 019830 NDA B. Braun Medical Inc. 0264-9594 0264-9594-10 24 CONTAINER in 1 CASE (0264-9594-10) > 500 mL in 1 CONTAINER

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/100ML
Approval Date:Apr 8, 1992TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength400MG/100ML
Approval Date:Apr 8, 1992TE:APRLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength800MG/100ML
Approval Date:Apr 8, 1992TE:APRLD:No


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