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Last Updated: December 7, 2019

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Details for New Drug Application (NDA): 020986

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NDA 020986 describes NOVOLOG PENFILL, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from four suppliers. There are two patents protecting this drug. Additional details are available on the NOVOLOG PENFILL profile page.

The generic ingredient in NOVOLOG PENFILL is insulin aspart recombinant. There are forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the insulin aspart recombinant profile page.
Summary for 020986
Tradename:NOVOLOG PENFILL
Applicant:Novo Nordisk Inc
Ingredient:insulin aspart recombinant
Patents:23
Pharmacology for NDA: 020986
Medical Subject Heading (MeSH) Categories for 020986
Suppliers and Packaging for NDA: 020986
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOVOLOG insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986 NDA Novo Nordisk 0169-2001 0169-2001-90 1 VIAL, GLASS in 1 CARTON (0169-2001-90) > 10 mL in 1 VIAL, GLASS
NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986 NDA Novo Nordisk 0169-2001 0169-2001-90 1 VIAL, GLASS in 1 CARTON (0169-2001-90) > 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength1000 UNITS/10ML (100 UNITS/ML)
Approval Date:Jun 7, 2000TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Jun 7, 2000TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 23, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 30, 2023Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 020986

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NOVOLOG PENFILL insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-002 Jun 7, 2000   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG INNOLET insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-004 Apr 23, 2004   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-001 Jun 7, 2000   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG PENFILL insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-002 Jun 7, 2000   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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