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Details for New Drug Application (NDA): 086364

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NDA 086364 describes LARYNG-O-JET KIT, which is a drug marketed by Intl Medication and is included in one NDA. It is available from two suppliers. Additional details are available on the LARYNG-O-JET KIT profile page.

The generic ingredient in LARYNG-O-JET KIT 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: 086364

Tradename:
LARYNG-O-JET KIT
Applicant:
Intl Medication
Ingredient:
lidocaine hydrochloride
Patents:0
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 086364

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 086364

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LARYNG-O-JET KIT
lidocaine hydrochloride
SOLUTION;TOPICAL 086364 ANDA Amphastar Pharmaceuticals, Inc. 0548-6300 0548-6300-00 25 VIAL in 1 CARTON (0548-6300-00) > 4 mL in 1 VIAL
LARYNG-O-JET KIT
lidocaine hydrochloride
SOLUTION;TOPICAL 086364 ANDA International Medication Systems, Limited 76329-6300 76329-6300-5 25 VIAL in 1 CARTON (76329-6300-5) > 4 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength4%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No


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