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Generated: December 15, 2018

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Details for New Drug Application (NDA): 080429

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NDA 080429 describes ANESTACON, which is a drug marketed by Bluepharma and is included in one NDA. It is available from one supplier. Additional details are available on the ANESTACON profile page.

The generic ingredient in ANESTACON is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 080429
Ingredient:lidocaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 080429
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 080429
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANESTACON lidocaine hydrochloride JELLY;TOPICAL 080429 ANDA Hi-Tech Pharmacal Co., Inc. 50383-772 50383-772-15 1 BOTTLE in 1 CARTON (50383-772-15) > 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:JELLY;TOPICALStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson
Cantor Fitzgerald
Boehringer Ingelheim
Daiichi Sankyo

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