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Last Updated: January 24, 2020

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Details for New Drug Application (NDA): 021148

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NDA 021148 describes NORDITROPIN NORDIFLEX, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the NORDITROPIN NORDIFLEX profile page.

The generic ingredient in NORDITROPIN NORDIFLEX is somatropin. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the somatropin profile page.
Summary for 021148
Tradename:NORDITROPIN NORDIFLEX
Applicant:Novo Nordisk Inc
Ingredient:somatropin
Patents:22
Formulation / Manufacturing:see details
Pharmacology for NDA: 021148
Suppliers and Packaging for NDA: 021148
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORDITROPIN somatropin INJECTABLE;INJECTION 021148 NDA Novo Nordisk 0169-7703 0169-7703-21 1 SYRINGE in 1 CARTON (0169-7703-21) > 3 mL in 1 SYRINGE
NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148 NDA Novo Nordisk 0169-7703 0169-7703-21 1 SYRINGE in 1 CARTON (0169-7703-21) > 3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5MG/1.5ML
Approval Date:Jun 20, 2000TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/1.5ML
Approval Date:Jun 20, 2000TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength15MG/1.5ML
Approval Date:Jun 20, 2000TE:RLD:No

Expired US Patents for NDA 021148

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-004 Oct 1, 2004   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-011 Jan 23, 2015   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-008 Mar 1, 2010   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin INJECTABLE;INJECTION 021148-008 Mar 1, 2010   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-007 Mar 10, 2009   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN somatropin INJECTABLE;INJECTION 021148-001 Jun 20, 2000   Start Trial   Start Trial
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin INJECTABLE;INJECTION 021148-007 Mar 10, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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