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Generated: May 24, 2017

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Details for New Drug Application (NDA): 208471

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NDA 208471 describes ADLYXIN, which is a drug marketed by Sanofi-aventis Us and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the ADLYXIN profile page.

The generic ingredient in ADLYXIN is lixisenatide. One supplier is listed for this compound. Additional details are available on the lixisenatide profile page.

Summary for NDA: 208471

Formulation / Manufacturing:see details

Pharmacology for NDA: 208471

Suppliers and Packaging for NDA: 208471

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;SUBCUTANEOUS 208471 NDA Sanofi-Aventis U.S. LLC 0024-5745 0024-5745-02 1 KIT in 1 CARTON (0024-5745-02) * 3 mL in 1 SYRINGE (0024-5741-01) * 3 mL in 1 SYRINGE (0024-5740-00)
SOLUTION;SUBCUTANEOUS 208471 NDA Sanofi-Aventis U.S. LLC 0024-5747 0024-5747-02 2 SYRINGE in 1 CARTON (0024-5747-02) > 3 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength0.15MG/3ML (0.05MG/ML)
Approval Date:Jul 27, 2016TE:RLD:Yes
Patent:8,882,721Patent Expiration:Jun 28, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:9,072,836Patent Expiration:Mar 15, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:9,084,853Patent Expiration:Oct 5, 2031Product Flag?YSubstance Flag?Delist Request?

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