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Generated: September 22, 2018

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Details for New Drug Application (NDA): 208673

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NDA 208673 describes SOLIQUA 100/33, which is a drug marketed by Sanofi-aventis Us and is included in one NDA. It is available from one supplier. There are twenty-five patents protecting this drug. Additional details are available on the SOLIQUA 100/33 profile page.

The generic ingredient in SOLIQUA 100/33 is insulin glargine; lixisenatide. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glargine; lixisenatide profile page.
Summary for 208673
Tradename:SOLIQUA 100/33
Applicant:Sanofi-aventis Us
Ingredient:insulin glargine; lixisenatide
Patents:25
Generic Entry Opportunity Date for 208673
Generic Entry Date for 208673*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 208673
Suppliers and Packaging for NDA: 208673
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLIQUA 100/33 insulin glargine; lixisenatide SOLUTION;SUBCUTANEOUS 208673 NDA Sanofi-Aventis U.S. LLC 0024-5761 0024-5761-05 5 SYRINGE in 1 CARTON (0024-5761-05) > 3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML)
Approval Date:Nov 21, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 27, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 21, 2019
Regulatory Exclusivity Use:NEW COMBINATION
Patent:➤ Try a Free TrialPatent Expiration:Aug 2, 2032Product Flag?YSubstance Flag?Delist Request?

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