Application 209806
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;500MG | Yes | No |
| 002 | SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;1GM | Yes | No |
| 003 | SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 7.5MG;500MG | Yes | No |
| 004 | SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 7.5MG;1GM | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209806-001 | SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | |
| N209806-002 | SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | |
| N209806-003 | SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | |
| N209806-004 | SEGLUROMET | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209806-001 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | |
| N209806-001 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | |
| N209806-001 | 8080580 | 2031-12-19 | U-2214 | Drug substance, Drug product | 2018-01-16 |
| N209806-002 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | |
| N209806-002 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | |
| N209806-002 | 8080580 | 2031-12-19 | U-2214 | Drug substance, Drug product | 2018-01-16 |
| N209806-003 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | |
| N209806-003 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | |
| N209806-003 | 8080580 | 2031-12-19 | U-2214 | Drug substance, Drug product | 2018-01-16 |
| N209806-004 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | |
| N209806-004 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | |
| N209806-004 | 8080580 | 2031-12-19 | U-2214 | Drug substance, Drug product | 2018-01-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N209806-001 | SEGLUROMET | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-002 | SEGLUROMET | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-003 | SEGLUROMET | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-004 | SEGLUROMET | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-001 | SEGLUROMET | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-002 | SEGLUROMET | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-003 | SEGLUROMET | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-004 | SEGLUROMET | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-001 | SEGLUROMET | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-002 | SEGLUROMET | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-003 | SEGLUROMET | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-004 | SEGLUROMET | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209806-001 | SEGLUROMET | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209806-002 | SEGLUROMET | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209806-003 | SEGLUROMET | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209806-004 | SEGLUROMET | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209806-001 | SEGLUROMET | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209806-002 | SEGLUROMET | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209806-003 | SEGLUROMET | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209806-004 | SEGLUROMET | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209806-001 | SEGLUROMET | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209806-002 | SEGLUROMET | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209806-003 | SEGLUROMET | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209806-004 | SEGLUROMET | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209806-001 | SEGLUROMET | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209806-002 | SEGLUROMET | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209806-003 | SEGLUROMET | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209806-004 | SEGLUROMET | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209806-001 | SEGLUROMET | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209806-002 | SEGLUROMET | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209806-003 | SEGLUROMET | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209806-004 | SEGLUROMET | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209806-001 | SEGLUROMET | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209806-002 | SEGLUROMET | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209806-003 | SEGLUROMET | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209806-004 | SEGLUROMET | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209806-001 | SEGLUROMET | 2.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209806-002 | SEGLUROMET | 2.5MG;1GM | TABLET / ORAL | RLD | 2017-12-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209806-003 | SEGLUROMET | 7.5MG;500MG | TABLET / ORAL | RLD | 2017-12-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209806-004 | SEGLUROMET | 7.5MG;1GM | TABLET / ORAL | RLD, RS | 2017-12-19 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N209806-001 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-001 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-001 | 8080580 | 2031-12-19 | U-2214 | Drug substance, Drug product | 2018-01-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209806-002 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-002 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-002 | 8080580 | 2031-12-19 | U-2214 | Drug substance, Drug product | 2018-01-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209806-003 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-003 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-003 | 8080580 | 2031-12-19 | U-2214 | Drug substance, Drug product | 2018-01-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209806-004 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-004 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209806-004 | 8080580 | 2031-12-19 | U-2214 | Drug substance, Drug product | 2018-01-16 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-001 | 8080580 | 2030-07-13 | U-2214 | Drug substance, Drug product | 2018-01-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-001 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-001 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-002 | 8080580 | 2030-07-13 | U-2214 | Drug substance, Drug product | 2018-01-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-002 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-002 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-003 | 8080580 | 2030-07-13 | U-2214 | Drug substance, Drug product | 2018-01-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-003 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-003 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-004 | 8080580 | 2030-07-13 | U-2214 | Drug substance, Drug product | 2018-01-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-004 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209806-004 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-001 | 8080580 | 2030-07-13 | U-2214 | Drug substance, Drug product | 2018-01-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-001 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-001 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-002 | 8080580 | 2030-07-13 | U-2214 | Drug substance, Drug product | 2018-01-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-002 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-002 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-003 | 8080580 | 2030-07-13 | U-2214 | Drug substance, Drug product | 2018-01-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-003 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-003 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-004 | 8080580 | 2030-07-13 | U-2214 | Drug substance, Drug product | 2018-01-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-004 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209806-004 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209806-001 | 8080580 | 2030-07-13 | U-2214 | Drug substance, Drug product | 2018-01-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209806-001 | 9308204 | 2030-10-21 | Drug product | 2018-01-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209806-001 | 9439902 | 2030-10-21 | U-2214 | 2018-01-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209806-002 | 8080580 | 2030-07-13 | U-2214 | Drug substance, Drug product | 2018-01-16 | 6a471c1ec25d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209806-001 | M-275 | 2024-09-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209806-002 | M-275 | 2024-09-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209806-003 | M-275 | 2024-09-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209806-004 | M-275 | 2024-09-17 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209806-001 | M-275 | 2024-09-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209806-002 | M-275 | 2024-09-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209806-003 | M-275 | 2024-09-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209806-004 | M-275 | 2024-09-17 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209806-001 | M-275 | 2024-09-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209806-002 | M-275 | 2024-09-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209806-003 | M-275 | 2024-09-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209806-004 | M-275 | 2024-09-17 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209806-001 | M-275 | 2024-09-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209806-002 | M-275 | 2024-09-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209806-003 | M-275 | 2024-09-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209806-004 | M-275 | 2024-09-17 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N209806-001 | M-275 | 2024-09-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209806-002 | M-275 | 2024-09-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209806-003 | M-275 | 2024-09-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209806-004 | M-275 | 2024-09-17 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209806-001 | M-275 | 2024-09-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209806-002 | M-275 | 2024-09-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209806-003 | M-275 | 2024-09-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209806-004 | M-275 | 2024-09-17 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209806-001 | M-275 | 2024-09-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209806-002 | M-275 | 2024-09-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209806-003 | M-275 | 2024-09-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209806-004 | M-275 | 2024-09-17 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209806-001 | M-275 | 2024-09-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209806-002 | M-275 | 2024-09-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209806-003 | M-275 | 2024-09-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209806-004 | M-275 | 2024-09-17 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N209806-001 | M-275 | 2024-09-17 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N209806-002 | M-275 | 2024-09-17 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N209806-003 | M-275 | 2024-09-17 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N209806-004 | M-275 | 2024-09-17 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209806-001 | NCE | 2022-12-19 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209806-001 | M-275 | 2024-09-17 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209806-002 | NCE | 2022-12-19 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209806-002 | M-275 | 2024-09-17 | 5c6f7cd8ea54… |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0006-5369 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5369 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5369 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-5369 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-5369 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5369 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5369 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5369 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5369 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5370 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5370 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5370 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-5370 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-5370 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5370 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5370 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5370 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5370 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5373 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5373 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5373 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-5373 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-5373 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5373 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5373 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5373 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5373 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5374 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5374 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5374 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-5374 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-5374 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5374 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5374 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5374 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-5374 | SEGLUROMET | ertugliflozin and metformin hydrochloride | Merck Sharp & Dohme Corp. | NDA | Current |
| 50090-6217 | SEGLUROMET | ertugliflozin and metformin hydrochloride | A-S Medication Solutions | NDA | Current |
| 50090-6218 | SEGLUROMET | ertugliflozin and metformin hydrochloride | A-S Medication Solutions | NDA | Current |
| 50090-6231 | SEGLUROMET | ertugliflozin and metformin hydrochloride | A-S Medication Solutions | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80777 | SUPPL | 2024-12-30 |
| 80776 | SUPPL | 2024-12-30 |
| 80764 | SUPPL | 2024-12-27 |
| 75430 | SUPPL | 2023-09-13 |
| 75421 | SUPPL | 2023-09-13 |
| 72364 | SUPPL | 2022-10-17 |
| 72363 | SUPPL | 2022-10-17 |
| 72336 | SUPPL | 2022-10-14 |
| 70391 | SUPPL | 2022-03-03 |
| 70390 | SUPPL | 2022-03-03 |
| 70384 | SUPPL | 2022-03-03 |
| 68690 | SUPPL | 2021-09-21 |
| 68666 | SUPPL | 2021-09-20 |
| 68665 | SUPPL | 2021-09-20 |
| 61678 | SUPPL | 2020-01-27 |
| 61659 | SUPPL | 2020-01-27 |
| 61658 | SUPPL | 2020-01-27 |
| 56187 | SUPPL | 2018-10-30 |
| 56154 | SUPPL | 2018-10-29 |
| 56153 | SUPPL | 2018-10-29 |
| 52810 | ORIG | 2018-03-05 |
| 50887 | ORIG | 2017-12-27 |
| 50793 | ORIG | 2017-12-19 |