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Generated: November 15, 2018

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Details for New Drug Application (NDA): 019959

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NDA 019959 describes NOVOLIN N, which is a drug marketed by Novo Nordisk Inc and is included in two NDAs. It is available from three suppliers. Additional details are available on the NOVOLIN N profile page.

The generic ingredient in NOVOLIN N is insulin susp isophane recombinant human. There are forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the insulin susp isophane recombinant human profile page.
Summary for 019959
Tradename:NOVOLIN N
Applicant:Novo Nordisk Inc
Ingredient:insulin susp isophane recombinant human
Patents:0
Suppliers and Packaging for NDA: 019959
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOVOLIN N insulin susp isophane recombinant human INJECTABLE;INJECTION 019959 NDA Novo Nordisk 0169-1834 0169-1834-02 1 VIAL in 1 CARTON (0169-1834-02) > 10 mL in 1 VIAL
NOVOLIN N insulin susp isophane recombinant human INJECTABLE;INJECTION 019959 NDA Novo Nordisk 0169-1834 0169-1834-11 1 VIAL in 1 CARTON (0169-1834-11) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Jul 1, 1991TE:RLD:Yes

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