Application 210874
- Type
- NDA
- Sponsor
- ASTRAZENECA AB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QTERNMET XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 2.5MG;1GM;EQ 2.5MG BASE | Yes | No |
| 002 | QTERNMET XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;1GM;EQ 2.5MG BASE | Yes | No |
| 003 | QTERNMET XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;1GM;EQ 5MG BASE | Yes | No |
| 004 | QTERNMET XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG;1GM;EQ 5MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210874-001 | QTERNMET XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | |
| N210874-002 | QTERNMET XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | |
| N210874-003 | QTERNMET XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | |
| N210874-004 | QTERNMET XR | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N210874-001 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2019-05-24 |
| N210874-001 | 6515117*PED | 2026-04-04 | Pediatric extension | ||
| N210874-001 | 8501698 | 2027-06-20 | U-493 | Drug product | 2019-05-24 |
| N210874-001 | 8501698*PED | 2027-12-20 | Pediatric extension | ||
| N210874-001 | 8716251 | 2028-03-21 | Drug product | 2019-05-24 | |
| N210874-001 | 8716251*PED | 2028-09-21 | Pediatric extension | ||
| N210874-001 | 7919598 | 2029-12-16 | Drug substance | 2019-05-24 | |
| N210874-001 | 7919598*PED | 2030-06-16 | Pediatric extension | ||
| N210874-001 | 9616028 | 2030-11-12 | Drug product | 2019-05-24 | |
| N210874-001 | 9616028*PED | 2031-05-12 | Pediatric extension | ||
| N210874-002 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2019-05-24 |
| N210874-002 | 6515117*PED | 2026-04-04 | Pediatric extension | ||
| N210874-002 | 8501698 | 2027-06-20 | U-493 | Drug product | 2019-05-24 |
| N210874-002 | 8501698*PED | 2027-12-20 | Pediatric extension | ||
| N210874-002 | 8716251 | 2028-03-21 | Drug product | 2019-05-24 | |
| N210874-002 | 8716251*PED | 2028-09-21 | Pediatric extension | ||
| N210874-002 | 7919598 | 2029-12-16 | Drug substance | 2019-05-24 | |
| N210874-002 | 7919598*PED | 2030-06-16 | Pediatric extension | ||
| N210874-002 | 9616028 | 2030-11-12 | Drug product | 2019-05-24 | |
| N210874-002 | 9616028*PED | 2031-05-12 | Pediatric extension | ||
| N210874-003 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2019-05-24 |
| N210874-003 | 6515117*PED | 2026-04-04 | Pediatric extension | ||
| N210874-003 | 8501698 | 2027-06-20 | U-493 | Drug product | 2019-05-24 |
| N210874-003 | 8501698*PED | 2027-12-20 | Pediatric extension | ||
| N210874-003 | 8716251 | 2028-03-21 | Drug product | 2019-05-24 | |
| N210874-003 | 8716251*PED | 2028-09-21 | Pediatric extension | ||
| N210874-003 | 7919598 | 2029-12-16 | Drug substance | 2019-05-24 | |
| N210874-003 | 7919598*PED | 2030-06-16 | Pediatric extension | ||
| N210874-003 | 9616028 | 2030-11-12 | Drug product | 2019-05-24 | |
| N210874-003 | 9616028*PED | 2031-05-12 | Pediatric extension | ||
| N210874-004 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2019-05-24 |
| N210874-004 | 6515117*PED | 2026-04-04 | Pediatric extension | ||
| N210874-004 | 8501698 | 2027-06-20 | U-493 | Drug product | 2019-05-24 |
| N210874-004 | 8501698*PED | 2027-12-20 | Pediatric extension | ||
| N210874-004 | 8716251 | 2028-03-21 | Drug product | 2019-05-24 | |
| N210874-004 | 8716251*PED | 2028-09-21 | Pediatric extension | ||
| N210874-004 | 7919598 | 2029-12-16 | Drug substance | 2019-05-24 | |
| N210874-004 | 7919598*PED | 2030-06-16 | Pediatric extension | ||
| N210874-004 | 9616028 | 2030-11-12 | Drug product | 2019-05-24 | |
| N210874-004 | 9616028*PED | 2031-05-12 | Pediatric extension |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | QTERNMET XR | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | QTERNMET XR | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | QTERNMET XR | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | QTERNMET XR | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N210874-001 | QTERNMET XR | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210874-002 | QTERNMET XR | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210874-003 | QTERNMET XR | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210874-004 | QTERNMET XR | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210874-001 | QTERNMET XR | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210874-002 | QTERNMET XR | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210874-003 | QTERNMET XR | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210874-004 | QTERNMET XR | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210874-001 | QTERNMET XR | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210874-002 | QTERNMET XR | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210874-003 | QTERNMET XR | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210874-004 | QTERNMET XR | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210874-001 | QTERNMET XR | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210874-002 | QTERNMET XR | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210874-003 | QTERNMET XR | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210874-004 | QTERNMET XR | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210874-001 | QTERNMET XR | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210874-002 | QTERNMET XR | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210874-003 | QTERNMET XR | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210874-004 | QTERNMET XR | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210874-001 | QTERNMET XR | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210874-002 | QTERNMET XR | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210874-003 | QTERNMET XR | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210874-004 | QTERNMET XR | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210874-001 | QTERNMET XR | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210874-002 | QTERNMET XR | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210874-003 | QTERNMET XR | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210874-004 | QTERNMET XR | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210874-001 | QTERNMET XR | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210874-002 | QTERNMET XR | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210874-003 | QTERNMET XR | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210874-004 | QTERNMET XR | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210874-001 | QTERNMET XR | 2.5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210874-002 | QTERNMET XR | 5MG;1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210874-003 | QTERNMET XR | 5MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210874-004 | QTERNMET XR | 10MG;1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2019-05-02 | 5bbf6a4d5a75… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2019-05-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | 6515117*PED | 2026-04-04 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | 8501698 | 2027-06-20 | U-493 | Drug product | 2019-05-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | 8501698*PED | 2027-12-20 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | 8716251 | 2028-03-21 | Drug product | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | 8716251*PED | 2028-09-21 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | 7919598 | 2029-12-16 | Drug substance | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | 7919598*PED | 2030-06-16 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | 9616028 | 2030-11-12 | Drug product | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-001 | 9616028*PED | 2031-05-12 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2019-05-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | 6515117*PED | 2026-04-04 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | 8501698 | 2027-06-20 | U-493 | Drug product | 2019-05-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | 8501698*PED | 2027-12-20 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | 8716251 | 2028-03-21 | Drug product | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | 8716251*PED | 2028-09-21 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | 7919598 | 2029-12-16 | Drug substance | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | 7919598*PED | 2030-06-16 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | 9616028 | 2030-11-12 | Drug product | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-002 | 9616028*PED | 2031-05-12 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2019-05-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | 6515117*PED | 2026-04-04 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | 8501698 | 2027-06-20 | U-493 | Drug product | 2019-05-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | 8501698*PED | 2027-12-20 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | 8716251 | 2028-03-21 | Drug product | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | 8716251*PED | 2028-09-21 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | 7919598 | 2029-12-16 | Drug substance | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | 7919598*PED | 2030-06-16 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | 9616028 | 2030-11-12 | Drug product | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-003 | 9616028*PED | 2031-05-12 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | 6515117 | 2025-10-04 | U-493 | Drug substance, Drug product | 2019-05-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | 6515117*PED | 2026-04-04 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | 8501698 | 2027-06-20 | U-493 | Drug product | 2019-05-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | 8501698*PED | 2027-12-20 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | 8716251 | 2028-03-21 | Drug product | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | 8716251*PED | 2028-09-21 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | 7919598 | 2029-12-16 | Drug substance | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | 7919598*PED | 2030-06-16 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | 9616028 | 2030-11-12 | Drug product | 2019-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210874-004 | 9616028*PED | 2031-05-12 | Pediatric extension | 84e616aacf4f… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-14 00:12 UTC | 2019-12 | N210874-001 | NP | 2022-05-02 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N210874-002 | NP | 2022-05-02 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N210874-003 | NP | 2022-05-02 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N210874-004 | NP | 2022-05-02 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N210874-001 | NP | 2022-05-02 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N210874-002 | NP | 2022-05-02 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N210874-003 | NP | 2022-05-02 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N210874-004 | NP | 2022-05-02 | b00525d2431f… |
| 2023-01-26 05:58 UTC | 2023-01 | N210874-001 | NP | 2022-05-02 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N210874-002 | NP | 2022-05-02 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N210874-003 | NP | 2022-05-02 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N210874-004 | NP | 2022-05-02 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N210874-001 | NP | 2022-05-02 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N210874-002 | NP | 2022-05-02 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N210874-003 | NP | 2022-05-02 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N210874-004 | NP | 2022-05-02 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N210874-001 | NP | 2022-05-02 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N210874-002 | NP | 2022-05-02 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N210874-003 | NP | 2022-05-02 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N210874-004 | NP | 2022-05-02 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N210874-001 | NP | 2022-05-02 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N210874-002 | NP | 2022-05-02 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N210874-003 | NP | 2022-05-02 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N210874-004 | NP | 2022-05-02 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N210874-001 | NP | 2022-05-02 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N210874-002 | NP | 2022-05-02 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N210874-003 | NP | 2022-05-02 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N210874-004 | NP | 2022-05-02 | cb3db0bc1861… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0310-6925 | QTERNMET | dapagliflozin saxagliptin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6950 | QTERNMET | dapagliflozin saxagliptin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6975 | QTERNMET | dapagliflozin saxagliptin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-6990 | QTERNMET | dapagliflozin saxagliptin and metformin hydrochloride | AstraZeneca Pharmaceuticals LP | NDA | Current |