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Details for New Drug Application (NDA): 206538

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NDA 206538 describes TOUJEO SOLOSTAR, which is a drug marketed by Sanofi Us Services and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the TOUJEO SOLOSTAR profile page.

The generic ingredient in TOUJEO SOLOSTAR is insulin glargine recombinant. There are thirty-eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.

Summary for NDA: 206538

Tradename:
TOUJEO SOLOSTAR
Applicant:
Sanofi Us Services
Ingredient:
insulin glargine recombinant
Patents:10

Pharmacology for NDA: 206538

Ingredient-typeInsulin

Suppliers and Packaging for NDA: 206538

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOUJEO SOLOSTAR
insulin glargine recombinant
SOLUTION;SUBCUTANEOUS 206538 NDA Sanofi-Aventis U.S. LLC 0024-5869 0024-5869-03 3 SYRINGE in 1 CARTON (0024-5869-03) > 1.5 mL in 1 SYRINGE (0024-5869-01)
TOUJEO SOLOSTAR
insulin glargine recombinant
SOLUTION;SUBCUTANEOUS 206538 NDA Sanofi-Aventis U.S. LLC 0024-5869 0024-5869-05 5 SYRINGE in 1 CARTON (0024-5869-05) > 1.5 mL in 1 SYRINGE (0024-5869-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength300 UNITS/ML (300 UNITS/ML)
Approval Date:Feb 25, 2015TE:RLD:Yes
Patent:7,918,833*PEDPatent Expiration:Mar 23, 2028Product Flag?Substance Flag?Delist Request?Y
Patent:8,512,297Patent Expiration:Sep 15, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,556,864Patent Expiration:Mar 3, 2024Product 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.

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