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Generated: April 26, 2017

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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 two suppliers. There are fourteen 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. Five suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.

Summary for NDA: 206538


Pharmacology for NDA: 206538


Suppliers and Packaging for NDA: 206538

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
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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