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Details for New Drug Application (NDA): 203314

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NDA 203314 describes TRESIBA, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the TRESIBA profile page.

The generic ingredient in TRESIBA is insulin degludec. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin degludec profile page.

Summary for NDA: 203314

Novo Nordisk Inc
insulin degludec

Pharmacology for NDA: 203314


Suppliers and Packaging for NDA: 203314

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
insulin degludec
SOLUTION;SUBCUTANEOUS 203314 NDA Novo Nordisk 0169-2550 0169-2550-13 3 SYRINGE, PLASTIC in 1 CARTON (0169-2550-13) > 3 mL in 1 SYRINGE, PLASTIC
insulin degludec
SOLUTION;SUBCUTANEOUS 203314 NDA Novo Nordisk 0169-2550 0169-2550-97 1 SYRINGE, PLASTIC in 1 CARTON (0169-2550-97) > 3 mL in 1 SYRINGE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Sep 25, 2015TE:RLD:No
Patent:6,899,699Patent Expiration:Jan 2, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,615,532Patent Expiration:May 25, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:7,686,786Patent Expiration:Aug 3, 2026Product Flag?YSubstance Flag?Delist Request?

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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.