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Generated: May 27, 2019

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Details for New Drug Application (NDA): 088295

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NDA 088295 describes LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira, Intl Medication, Mylan Labs Ltd, and West-ward Pharms Int, and is included in ten NDAs. It is available from eleven 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. Forty-six suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 088295
Tradename:LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Hospira
Ingredient:lidocaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 088295
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 088295
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 088295 ANDA Hospira, Inc. 0409-4283 0409-4283-01 5 CELLO PACK in 1 PACKAGE (0409-4283-01) > 5 AMPULE in 1 CELLO PACK (0409-4283-25) > 5 mL in 1 AMPULE (0409-4283-11)
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 088295 ANDA IT3 Medical LLC 70529-018 70529-018-01 1 KIT in 1 PACKAGE (70529-018-01) * 50 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET * 5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4%
Approval Date:May 17, 1984TE:RLD:No

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