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Last Updated: October 20, 2019

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Details for New Drug Application (NDA): 021081

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NDA 021081 describes LANTUS SOLOSTAR, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from three suppliers. There are eighteen patents protecting this drug. Additional details are available on the LANTUS SOLOSTAR profile page.

The generic ingredient in LANTUS SOLOSTAR is insulin glargine recombinant. There are forty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.
Summary for 021081
Tradename:LANTUS SOLOSTAR
Applicant:Sanofi Aventis Us
Ingredient:insulin glargine recombinant
Patents:21
Pharmacology for NDA: 021081
Ingredient-typeInsulin
Suppliers and Packaging for NDA: 021081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081 NDA sanofi-aventis U.S. LLC 0088-2219 0088-2219-00 1 SYRINGE in 1 CARTON (0088-2219-00) > 3 mL in 1 SYRINGE
LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081 NDA sanofi-aventis U.S. LLC 0088-2219 0088-2219-00 1 SYRINGE in 1 CARTON (0088-2219-00) > 3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Apr 20, 2000TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jan 23, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Dec 13, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Mar 23, 2028Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021081

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000   Start Trial   Start Trial
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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