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Details for New Drug Application (NDA): 017584

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NDA 017584 describes LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Intl Medication, Fresenius Kabi Usa, Hospira, West-ward Pharms Int, Aurobindo Pharma Ltd, and Mylan Labs Ltd, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.

Summary for NDA: 017584

Fresenius Kabi Usa
lidocaine hydrochloride
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 017584

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 017584

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lidocaine hydrochloride
INJECTABLE;INJECTION 017584 NDA Cardinal Health 55154-9390 55154-9390-5 5 VIAL, SINGLE-DOSE in 1 BAG (55154-9390-5) > 5 mL in 1 VIAL, SINGLE-DOSE
lidocaine hydrochloride
INJECTABLE;INJECTION 017584 NDA APP Pharmaceuticals, LLC 63323-208 63323-208-05 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-208-05) > 5 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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