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AstraZeneca
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Dow
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Moodys
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Colorcon
Teva

Generated: February 19, 2018

DrugPatentWatch Database Preview

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 two suppliers. 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 recombinant. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the somatropin recombinant profile page.
Summary for 021148
Tradename:NORDITROPIN NORDIFLEX
Applicant:Novo Nordisk Inc
Ingredient:somatropin recombinant
Patents:15
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 recombinant INJECTABLE;INJECTION 021148 NDA Novo Nordisk 0169-7703 N 0169-7703-21
NORDITROPIN FLEXPRO somatropin recombinant INJECTABLE;INJECTION 021148 NDA Novo Nordisk 0169-7703 N 0169-7703-21

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 recombinant INJECTABLE;INJECTION 021148-006 Oct 1, 2004 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-004 Oct 1, 2004 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN somatropin recombinant INJECTABLE;INJECTION 021148-001 Jun 20, 2000 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN somatropin recombinant INJECTABLE;INJECTION 021148-002 Jun 20, 2000 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN somatropin recombinant INJECTABLE;INJECTION 021148-003 Jun 20, 2000 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin recombinant INJECTABLE;INJECTION 021148-009 Mar 1, 2010 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN NORDIFLEX somatropin recombinant INJECTABLE;INJECTION 021148-005 Oct 1, 2004 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN FLEXPRO somatropin recombinant INJECTABLE;INJECTION 021148-011 Jan 23, 2015 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN somatropin recombinant INJECTABLE;INJECTION 021148-002 Jun 20, 2000 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NORDITROPIN somatropin recombinant INJECTABLE;INJECTION 021148-003 Jun 20, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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