Application 211566
- Type
- NDA
- Sponsor
- ZYDUS WORLDWIDE DMCC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SITAGLIPTIN | SITAGLIPTIN | TABLET; ORAL | 25MG | No | No |
| 002 | ZITUVIO | SITAGLIPTIN | TABLET;ORAL | 50MG | Yes | No |
| 003 | ZITUVIO | SITAGLIPTIN | TABLET;ORAL | 100MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N211566-001 | ZITUVIO | SITAGLIPTIN | 25MG | TABLET / ORAL | RLD | 2023-10-18 | |
| N211566-002 | ZITUVIO | SITAGLIPTIN | 50MG | TABLET / ORAL | RLD | 2023-10-18 | |
| N211566-003 | ZITUVIO | SITAGLIPTIN | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | |
| N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | |
| N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 |
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 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211566-002 | ZITUVIO | 50MG | TABLET / ORAL | RLD | 2023-10-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211566-003 | ZITUVIO | 100MG | TABLET / ORAL | RLD, RS | 2023-10-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211566-001 | ZITUVIO | 25MG | TABLET / ORAL | RLD | 2023-10-18 | 8072bd15b7f6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211566-002 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211566-003 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211566-001 | 10925871 | 2035-02-25 | Drug product | 2023-12-18 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| ZITUVIO | SITAGLIPTIN | Zydus Pharmaceuticals (USA) Inc. | abfdea45-c0ca-41e3-a510-e89810bc9cfe | 2025-01-31 | Warnings, Adverse reactions | 211566 NDA211566 |
| ZITUVIO | SITAGLIPTIN | Zydus Lifesciences Limited | b2da9d77-154b-48f7-8793-3f4a24dfafc6 | 2025-01-31 | Warnings, Adverse reactions | 211566 NDA211566 |
| Sitagliptin | SITAGLIPTIN | Zydus Pharmaceuticals (USA) Inc. | 6a970e80-b753-48fa-9fff-87e7a5044982 | 2025-01-31 | Warnings, Adverse reactions | 211566 NDA211566 |
| Sitagliptin | SITAGLIPTIN | Zydus Lifesciences Limited | e5ac97e8-3a0b-4750-8e3f-337412570746 | 2025-01-31 | Warnings, Adverse reactions | 211566 NDA211566 |