Application 215503
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIRAGLUTIDE | LIRAGLUTIDE | SOLUTION;SUBCUTANEOUS | 18MG/3ML (6MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215503-001 | LIRAGLUTIDE | LIRAGLUTIDE | 18MG/3ML (6MG/ML) | SOLUTION / SUBCUTANEOUS | AP1 | 2024-12-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215503-001 | AP1 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A215503-001 | LIRAGLUTIDE | 18MG/3ML (6MG/ML) | SOLUTION / SUBCUTANEOUS | AP1 | 2024-12-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215503-001 | LIRAGLUTIDE | 18MG/3ML (6MG/ML) | SOLUTION / SUBCUTANEOUS | AP1 | 2024-12-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215503-001 | LIRAGLUTIDE | 18MG/3ML (6MG/ML) | SOLUTION / SUBCUTANEOUS | AP | 2024-12-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215503-001 | LIRAGLUTIDE | 18MG/3ML (6MG/ML) | SOLUTION / SUBCUTANEOUS | AP | 2024-12-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215503-001 | LIRAGLUTIDE | 18MG/3ML (6MG/ML) | SOLUTION / SUBCUTANEOUS | AP | 2024-12-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215503-001 | LIRAGLUTIDE | 18MG/3ML (6MG/ML) | SOLUTION / SUBCUTANEOUS | AP | 2024-12-23 | 03ed91905a0d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215503-001 | LIRAGLUTIDE | 18MG/3ML (6MG/ML) | SOLUTION / SUBCUTANEOUS | AP1 | 2024-12-23 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A215503-001 | AP1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215503-001 | AP1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215503-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215503-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215503-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215503-001 | AP | 1 | 03ed91905a0d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215503-001 | AP1 | 1 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Liraglutide | LIRAGLUTIDE | Hikma Pharmaceuticals USA Inc. | 2100ec49-57b2-4330-ab5f-057ce9b7e4d0 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 215503 ANDA215503 |
| Liraglutide | LIRAGLUTIDE | Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) | 1a372465-d56b-2b80-e063-6394a90a3304 | 2024-12-03 | Warnings, Adverse reactions | 215503 ANDA215503 |
| Liraglutide | LIRAGLUTIDE | Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) | 1a36f43f-d734-97cc-e063-6294a90ae0da | 2024-12-02 | Warnings, Adverse reactions | 215503 ANDA215503 |
| Liraglutide | LIRAGLUTIDE | Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) | 1a36b801-41e2-2eed-e063-6294a90a6f27 | 2024-06-05 | Warnings, Adverse reactions | 215503 ANDA215503 |