Application 215866
- Type
- NDA
- Sponsor
- ELI LILLY CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MOUNJARO | TIRZEPATIDE | INJECTABLE;INJECTION | 2.5MG | No | No |
| 002 | MOUNJARO | TIRZEPATIDE | INJECTABLE;INJECTION | 5MG | No | No |
| 003 | MOUNJARO | TIRZEPATIDE | INJECTABLE;INJECTION | 7.5MG | No | No |
| 004 | MOUNJARO | TIRZEPATIDE | INJECTABLE;INJECTION | 10MG | No | No |
| 005 | MOUNJARO | TIRZEPATIDE | INJECTABLE;INJECTION | 12.5MG | No | No |
| 006 | MOUNJARO | TIRZEPATIDE | INJECTABLE;INJECTION | 15MG | No | No |
| 007 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 2.5MG/0.5ML (2.5MG/0.5ML) | Yes | Yes |
| 008 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 5MG/0.5ML (5MG/0.5ML) | Yes | Yes |
| 009 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 7.5MG/0.5ML (7.5MG/0.5ML) | Yes | Yes |
| 010 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 10MG/0.5ML (10MG/0.5ML) | Yes | Yes |
| 011 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 12.5MG/0.5ML (12.5MG/0.5ML) | Yes | Yes |
| 012 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 15MG/0.5ML (15MG/0.5ML) | Yes | Yes |
| 013 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 10MG/2.4ML (4.17MG/ML) | Yes | Yes |
| 014 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 20MG/2.4ML (8.33MG/ML) | Yes | Yes |
| 015 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 30MG/2.4ML (12.5MG/ML) | Yes | Yes |
| 016 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 40MG/2.4ML (16.7MG/ML) | Yes | Yes |
| 017 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 50MG/2.4ML (20.8MG/ML) | Yes | Yes |
| 018 | MOUNJARO | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 60MG/2.4ML (25MG/ML) | Yes | Yes |
| 019 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 10MG/2.4ML (4.17MG/ML) | Yes | Yes |
| 020 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 20MG/2.4ML (8.33MG/ML) | Yes | Yes |
| 021 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 30MG/2.4ML (12.5MG/ML) | Yes | Yes |
| 022 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 40MG/2.4ML (16.7MG/ML) | Yes | Yes |
| 023 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 50MG/2.4ML (20.8MG/ML) | Yes | Yes |
| 024 | MOUNJARO KWIKPEN | TIRZEPATIDE | SOLUTION;SUBCUTANEOUS | 60MG/2.4ML (25MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0002-1457 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1457 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1457 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1460 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1460 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1460 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1471 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1471 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1471 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1484 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1484 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1484 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1495 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1495 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1495 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1506 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1506 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
| 0002-1506 | MOUNJARO | tirzepatide | Eli Lilly and Company | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84798 | SUPPL | 2026-01-21 |
| 84797 | SUPPL | 2026-01-21 |
| 84788 | SUPPL | 2026-01-21 |
| 84787 | SUPPL | 2026-01-21 |
| 84722 | SUPPL | 2026-01-08 |
| 84721 | SUPPL | 2026-01-08 |
| 84716 | SUPPL | 2026-01-08 |
| 84514 | SUPPL | 2025-12-23 |
| 84507 | SUPPL | 2025-12-23 |
| 83557 | SUPPL | 2025-09-26 |
| 83541 | SUPPL | 2025-09-26 |
| 82379 | SUPPL | 2025-06-02 |
| 82350 | SUPPL | 2025-05-29 |
| 80489 | SUPPL | 2024-12-04 |
| 80138 | SUPPL | 2024-11-05 |
| 80137 | SUPPL | 2024-11-05 |
| 80136 | SUPPL | 2024-11-05 |
| 80132 | SUPPL | 2024-11-05 |
| 80131 | SUPPL | 2024-11-05 |
| 80130 | SUPPL | 2024-11-05 |
| 74960 | SUPPL | 2023-07-31 |
| 74959 | SUPPL | 2023-07-31 |
| 74957 | SUPPL | 2023-07-31 |
| 74956 | SUPPL | 2023-07-31 |
| 71307 | ORIG | 2022-06-15 |
| 71073 | ORIG | 2022-05-16 |
| 71068 | ORIG | 2022-05-13 |