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Generated: November 20, 2018

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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 three suppliers. 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. Three 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:18
Pharmacology for NDA: 020986
Ingredient-typeInsulin
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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Jan 19, 2001TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 28, 2019Product 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 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-001 Jun 7, 2000 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG INNOLET insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-004 Apr 23, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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