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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206697


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NDA 206697 describes EXENATIDE SYNTHETIC, which is a drug marketed by Amneal and is included in one NDA. It is available from one supplier. Additional details are available on the EXENATIDE SYNTHETIC profile page.

The generic ingredient in EXENATIDE SYNTHETIC is exenatide synthetic. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.
Summary for 206697
Tradename:EXENATIDE SYNTHETIC
Applicant:Amneal
Ingredient:exenatide synthetic
Patents:0
Pharmacology for NDA: 206697
Mechanism of ActionGlucagon-like Peptide-1 (GLP-1) Agonists
Suppliers and Packaging for NDA: 206697
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXENATIDE SYNTHETIC exenatide synthetic INJECTABLE;SUBCUTANEOUS 206697 ANDA Amneal Pharmaceuticals LLC 70121-1685 70121-1685-1 1 CARTRIDGE in 1 CARTON (70121-1685-1) / 1.2 mL in 1 CARTRIDGE
EXENATIDE SYNTHETIC exenatide synthetic INJECTABLE;SUBCUTANEOUS 206697 ANDA Amneal Pharmaceuticals LLC 70121-1686 70121-1686-1 1 CARTRIDGE in 1 CARTON (70121-1686-1) / 2.4 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300MCG/1.2ML (250MCG/ML)
Approval Date:Nov 19, 2024TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength600MCG/2.4ML (250MCG/ML)
Approval Date:Nov 19, 2024TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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