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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 is one patent 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 thirty-eight 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 NDA: 020986

Tradename:
NOVOLOG
Applicant:
Novo Nordisk Inc
Ingredient:
insulin aspart recombinant
Patents:13

Pharmacology for NDA: 020986

Ingredient-typeInsulin

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 0169-3303 0169-3303-12 5 CARTRIDGE in 1 CARTON (0169-3303-12) > 3 mL in 1 CARTRIDGE
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS 020986 NDA Novo Nordisk 0169-3303 0169-3303-12 5 CARTRIDGE in 1 CARTON (0169-3303-12) > 3 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength1000 UNITS/10ML (100 UNITS/ML)
Approval Date:Jun 7, 2000TE:RLD:Yes
Patent:5,866,538*PEDPatent Expiration:Dec 20, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Jun 7, 2000TE:RLD:Yes
Patent:5,866,538*PEDPatent Expiration:Dec 20, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Jan 19, 2001TE:RLD:Yes
Patent:5,866,538*PEDPatent Expiration:Dec 20, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020986

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NOVOLOG
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-001Jun 7, 20005,618,913*PED► subscribe
Novo Nordisk Inc
NOVOLOG INNOLET
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-004Apr 23, 20045,618,913*PED► subscribe
Novo Nordisk Inc
NOVOLOG PENFILL
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-002Jun 7, 20005,693,027*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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