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.
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 Action | Glucagon-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: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 300MCG/1.2ML (250MCG/ML) | ||||
| Approval Date: | Nov 19, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 600MCG/2.4ML (250MCG/ML) | ||||
| Approval Date: | Nov 19, 2024 | TE: | AP | RLD: | No | ||||
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