Application 216778
- Type
- NDA
- Sponsor
- ZYDUS LIFESCIENCES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZITUVIMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET, EXTENDED RELEASE;ORAL | 500MG;50MG | Yes | No |
| 002 | ZITUVIMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET, EXTENDED RELEASE;ORAL | 1GM;50MG | Yes | No |
| 003 | ZITUVIMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET, EXTENDED RELEASE;ORAL | 1GM;100MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216778-001 | ZITUVIMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | 500MG;50MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-18 | |
| N216778-002 | ZITUVIMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | 1GM;50MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-18 | |
| N216778-003 | ZITUVIMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | 1GM;100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2024-07-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216778-002 | ZITUVIMET XR | 1GM;50MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N216778-003 | ZITUVIMET XR | 1GM;100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2024-07-18 | 79d66fd596c7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216778-001 | ZITUVIMET XR | 500MG;50MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-18 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216778-002 | ZITUVIMET XR | 1GM;50MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2024-07-18 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N216778-003 | ZITUVIMET XR | 1GM;100MG | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2024-07-18 | 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 |
|---|---|---|---|---|---|---|
| ZITUVIMET XR | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Lifesciences Limited | 4bade493-499e-434a-97a0-26ca68917623 | 2026-01-05 | 216778 NDA216778 | |
| ZITUVIMET XR | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 2f635b36-e86a-4e53-8eaf-589917b5f342 | 2025-07-16 | Boxed warning, Warnings, Adverse reactions | 216778 NDA216778 |
| Sitagliptin and Metformin Hydrochloride | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | d3a728a0-decb-4340-8ee4-c5e27c13eb19 | 2024-08-31 | Boxed warning, Warnings, Adverse reactions | 216778 NDA216778 |
| Sitagliptin and Metformin Hydrochloride | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Zydus Lifesciences Limited | a07fa1d9-7171-4f2a-ab34-f8fa410364a6 | 2024-08-24 | 216778 NDA216778 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.