Details for New Drug Application (NDA): 214568
NDA 214568 describes LIRAGLUTIDE, which is a drug marketed by Biocon Pharma, Fresenius Kabi Usa, Hikma, Lupin, Mylan Institutional, Nanjing King Friend, Orbicular, Sandoz, and Teva Pharms, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the LIRAGLUTIDE profile page.
The generic ingredient in LIRAGLUTIDE is liraglutide. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the liraglutide profile page.
The generic ingredient in LIRAGLUTIDE is liraglutide. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the liraglutide profile page.
Summary for 214568
| Tradename: | LIRAGLUTIDE |
| Applicant: | Teva Pharms |
| Ingredient: | liraglutide |
| Patents: | 0 |
Pharmacology for NDA: 214568
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Suppliers and Packaging for NDA: 214568
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIRAGLUTIDE | liraglutide | SOLUTION;SUBCUTANEOUS | 214568 | ANDA | Teva Pharmaceuticals, Inc. | 0480-7250 | 0480-7250-46 | 5 SYRINGE, PLASTIC in 1 CARTON (0480-7250-46) / 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: | Aug 27, 2025 | TE: | AP2 | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 24, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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