Application 216743
- Type
- NDA
- Sponsor
- ZYDUS LIFESCIENCES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZITUVIMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET;ORAL | 500MG;50MG | Yes | No |
| 002 | ZITUVIMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET;ORAL | 1GM;50MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216743-001 | ZITUVIMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | |
| N216743-002 | ZITUVIMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 |
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 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | ea1830bbd6c7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216743-001 | ZITUVIMET | 500MG;50MG | TABLET / ORAL | RLD | 2023-11-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216743-002 | ZITUVIMET | 1GM;50MG | TABLET / ORAL | RLD, RS | 2023-11-03 | 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 |
|---|---|---|---|---|---|---|
| Sitagliptin and metformin hydrochloride | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Lifesciences Limited | e07abcb1-1f0c-4cad-8405-8eedba4b8ff8 | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 216743 NDA216743 |
| ZITUVIMET | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Lifesciences Limited | 0098dec4-f0e5-45d5-8aa4-5d0faf9ab142 | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 216743 NDA216743 |
| ZITUVIMET | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | eeda90a0-4941-4716-8684-f9f12cbdf3af | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 216743 NDA216743 |
| Sitagliptin and metformin hydrochloride | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | 4d812277-21a8-4de3-b728-e3fdd01305b5 | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 216743 NDA216743 |