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Generated: November 19, 2018

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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 nineteen 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 forty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.
Summary for 206538
Tradename:TOUJEO SOLOSTAR
Applicant:Sanofi Us Services
Ingredient:insulin glargine recombinant
Patents:20
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 MAX SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538 NDA Sanofi-Aventis U.S. LLC 0024-5869 0024-5869-00 1 SYRINGE in 1 CARTON (0024-5869-00) > 1.5 mL in 1 SYRINGE
TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538 NDA Sanofi-Aventis U.S. LLC 0024-5869 0024-5869-00 1 SYRINGE in 1 CARTON (0024-5869-00) > 1.5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength450 UNITS/1.5ML (300 UNITS/ML)
Approval Date:Feb 25, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 25, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Mar 23, 2028Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Sep 15, 2024Product Flag?YSubstance Flag?Delist Request?

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