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Details for New Drug Application (NDA): 021536

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NDA 021536 describes LEVEMIR 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 LEVEMIR PENFILL profile page.

The generic ingredient in LEVEMIR PENFILL is insulin detemir 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 detemir recombinant profile page.

Summary for NDA: 021536

Tradename:
LEVEMIR
Applicant:
Novo Nordisk Inc
Ingredient:
insulin detemir recombinant
Patents:14
Formulation / Manufacturing:see details

Pharmacology for NDA: 021536

Ingredient-typeInsulin

Suppliers and Packaging for NDA: 021536

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS 021536 NDA Novo Nordisk 0169-3687 0169-3687-12 1 VIAL, GLASS in 1 CARTON (0169-3687-12) > 10 mL in 1 VIAL, GLASS
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS 021536 NDA Novo Nordisk 0169-3687 0169-3687-12 1 VIAL, GLASS in 1 CARTON (0169-3687-12) > 10 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength1000 UNITS/10ML (100 UNITS/ML)
Approval Date:Jun 16, 2005TE:RLD:Yes
Patent:5,866,538Patent Expiration:Jun 20, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:5,750,497Patent Expiration:Jun 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Jun 16, 2005TE:RLD:No
Patent:5,866,538Patent Expiration:Jun 20, 2017Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021536

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 20056,011,007► subscribe
Novo Nordisk Inc
LEVEMIR INNOLET
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-003Jun 16, 20056,011,007► subscribe
Novo Nordisk Inc
LEVEMIR INNOLET
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-003Jun 16, 20056,869,930► 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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