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Generated: September 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080408

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NDA 080408 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 eight 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 NDA: 080408

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 080408

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 080408

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
lidocaine hydrochloride
INJECTABLE;INJECTION 080408 ANDA Hospira, Inc. 0409-4056 0409-4056-01 5 BLISTER PACK in 1 CARTON (0409-4056-01) > 1 AMPULE in 1 BLISTER PACK > 20 mL in 1 AMPULE (0409-4056-11)
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
lidocaine hydrochloride
INJECTABLE;INJECTION 080408 ANDA Hospira, Inc. 0409-4713 0409-4713-02 5 CELLO PACK in 1 PACKAGE (0409-4713-02) > 5 AMPULE in 1 CELLO PACK (0409-4713-26) > 5 mL in 1 AMPULE (0409-4713-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.5%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Baxter
AstraZeneca
Covington
Federal Trade Commission
Cipla
Fuji
Argus Health
Colorcon

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