Details for New Drug Application (NDA): 217590
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NDA 217590 describes LIRAGLUTIDE, which is a drug marketed by Hikma, Lupin Ltd, Nanjing King Friend, Orbicular, and Teva Pharms, and is included in five NDAs. It is available from eight suppliers. Additional details are available on the LIRAGLUTIDE profile page.
The generic ingredient in LIRAGLUTIDE is liraglutide. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the liraglutide profile page.
The generic ingredient in LIRAGLUTIDE is liraglutide. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the liraglutide profile page.
Summary for 217590
| Tradename: | LIRAGLUTIDE |
| Applicant: | Orbicular |
| Ingredient: | liraglutide |
| Patents: | 0 |
Pharmacology for NDA: 217590
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Suppliers and Packaging for NDA: 217590
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIRAGLUTIDE | liraglutide | SOLUTION;SUBCUTANEOUS | 217590 | ANDA | Cipla USA Inc. | 69097-920 | 69097-920-67 | 2 SYRINGE, PLASTIC in 1 CARTON (69097-920-67) / 3 mL in 1 SYRINGE, PLASTIC |
| LIRAGLUTIDE | liraglutide | SOLUTION;SUBCUTANEOUS | 217590 | ANDA | Cipla USA Inc. | 69097-920 | 69097-920-68 | 3 SYRINGE, PLASTIC in 1 CARTON (69097-920-68) / 3 mL in 1 SYRINGE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 18MG/3ML (6MG/ML) | ||||
| Approval Date: | Jan 14, 2026 | TE: | AP1 | RLD: | No | ||||
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