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Generated: November 18, 2018

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Details for New Drug Application (NDA): 020918

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NDA 020918 describes GLUCAGEN, which is a drug marketed by Novo Nordisk and is included in one NDA. It is available from two suppliers. Additional details are available on the GLUCAGEN profile page.

The generic ingredient in GLUCAGEN is glucagon hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glucagon hydrochloride profile page.
Summary for 020918
Tradename:GLUCAGEN
Applicant:Novo Nordisk
Ingredient:glucagon hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020918
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLUCAGEN glucagon hydrochloride INJECTABLE;INJECTION 020918 NDA Novo Nordisk 0169-7065 0169-7065-15 1 KIT in 1 KIT (0169-7065-15) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 SYRINGE, GLASS
GLUCAGEN glucagon hydrochloride INJECTABLE;INJECTION 020918 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0053 0597-0053-45 10 VIAL in 1 CARTON (0597-0053-45) > 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/VIAL
Approval Date:Jun 22, 1998TE:RLD:Yes

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