Application 022426
- Type
- NDA
- Sponsor
- TAKEDA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE;EQ 15MG BASE | Yes | No |
| 002 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE;EQ 30MG BASE | Yes | No |
| 003 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE;EQ 45MG BASE | Yes | Yes |
| 004 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 12.5MG BASE;EQ 15MG BASE | Yes | No |
| 005 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 12.5MG BASE;EQ 30MG BASE | Yes | No |
| 006 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | TABLET;ORAL | EQ 12.5MG BASE;EQ 45MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022426-001 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | EQ 25MG BASE;EQ 15MG BASE | TABLET / ORAL | RLD | 2013-01-25 | |
| N022426-002 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | EQ 25MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | |
| N022426-003 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | EQ 25MG BASE;EQ 45MG BASE | TABLET / ORAL | RLD, RS | 2013-01-25 | |
| N022426-004 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | |
| N022426-005 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | EQ 12.5MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | |
| N022426-006 | OSENI | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE | EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022426-001 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | |
| N022426-001 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | |
| N022426-002 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | |
| N022426-002 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | |
| N022426-003 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | |
| N022426-003 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | |
| N022426-004 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | |
| N022426-004 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | |
| N022426-005 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | |
| N022426-005 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | |
| N022426-006 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | |
| N022426-006 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 |
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 | N022426-001 | OSENI | EQ 25MG BASE;EQ 15MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-002 | OSENI | EQ 25MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-003 | OSENI | EQ 25MG BASE;EQ 45MG BASE | TABLET / ORAL | RLD, RS | 2013-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-004 | OSENI | EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-005 | OSENI | EQ 12.5MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-006 | OSENI | EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-001 | OSENI | EQ 25MG BASE;EQ 15MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-002 | OSENI | EQ 25MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-003 | OSENI | EQ 25MG BASE;EQ 45MG BASE | TABLET / ORAL | RLD, RS | 2013-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-004 | OSENI | EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-005 | OSENI | EQ 12.5MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-006 | OSENI | EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022426-001 | OSENI | EQ 25MG BASE;EQ 15MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022426-002 | OSENI | EQ 25MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022426-003 | OSENI | EQ 25MG BASE;EQ 45MG BASE | TABLET / ORAL | RLD, RS | 2013-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022426-004 | OSENI | EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022426-005 | OSENI | EQ 12.5MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022426-006 | OSENI | EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022426-001 | OSENI | EQ 25MG BASE;EQ 15MG BASE | TABLET / ORAL | RLD | 2013-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022426-002 | OSENI | EQ 25MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022426-003 | OSENI | EQ 25MG BASE;EQ 45MG BASE | TABLET / ORAL | RLD, RS | 2013-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022426-004 | OSENI | EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022426-005 | OSENI | EQ 12.5MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022426-006 | OSENI | EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022426-001 | OSENI | EQ 25MG BASE;EQ 15MG BASE | TABLET / ORAL | RLD | 2013-01-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022426-002 | OSENI | EQ 25MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022426-003 | OSENI | EQ 25MG BASE;EQ 45MG BASE | TABLET / ORAL | RLD, RS | 2013-01-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022426-004 | OSENI | EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022426-005 | OSENI | EQ 12.5MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022426-006 | OSENI | EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022426-001 | OSENI | EQ 25MG BASE;EQ 15MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022426-002 | OSENI | EQ 25MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022426-003 | OSENI | EQ 25MG BASE;EQ 45MG BASE | TABLET / ORAL | RLD, RS | 2013-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022426-004 | OSENI | EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022426-005 | OSENI | EQ 12.5MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022426-006 | OSENI | EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022426-001 | OSENI | EQ 25MG BASE;EQ 15MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022426-002 | OSENI | EQ 25MG BASE;EQ 30MG BASE | TABLET / ORAL | RLD | 2013-01-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022426-003 | OSENI | EQ 25MG BASE;EQ 45MG BASE | TABLET / ORAL | RLD, RS | 2013-01-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022426-004 | OSENI | EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2013-01-25 | 2680178bc6a6… |
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 | N022426-001 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-001 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-002 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-002 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-003 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-003 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-004 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-004 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-005 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-005 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-006 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022426-006 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-001 | 8173663 | 2025-03-15 | U-1338 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-001 | 8288539 | 2025-03-15 | Drug substance | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-001 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-001 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-002 | 8173663 | 2025-03-15 | U-1338 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-002 | 8288539 | 2025-03-15 | Drug substance | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-002 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-002 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-003 | 8173663 | 2025-03-15 | U-1338 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-003 | 8288539 | 2025-03-15 | Drug substance | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-003 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-003 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-004 | 8173663 | 2025-03-15 | U-1338 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-004 | 8288539 | 2025-03-15 | Drug substance | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-004 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-004 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-005 | 8173663 | 2025-03-15 | U-1338 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-005 | 8288539 | 2025-03-15 | Drug substance | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-005 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-005 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-006 | 8173663 | 2025-03-15 | U-1338 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-006 | 8288539 | 2025-03-15 | Drug substance | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-006 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022426-006 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022426-001 | 8173663 | 2025-03-15 | U-1338 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022426-001 | 8288539 | 2025-03-15 | Drug substance | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022426-001 | 7807689 | 2028-06-27 | U-1337 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022426-001 | 8637079 | 2029-06-04 | Drug product | 2014-02-13 | 6a471c1ec25d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022426-001 | M-177 | 2019-04-05 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022426-002 | M-177 | 2019-04-05 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022426-003 | M-177 | 2019-04-05 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022426-004 | M-177 | 2019-04-05 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022426-005 | M-177 | 2019-04-05 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022426-006 | M-177 | 2019-04-05 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N022426-001 | M-177 | 2019-04-05 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022426-002 | M-177 | 2019-04-05 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022426-003 | M-177 | 2019-04-05 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022426-004 | M-177 | 2019-04-05 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022426-005 | M-177 | 2019-04-05 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022426-006 | M-177 | 2019-04-05 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022426-001 | M-177 | 2019-04-05 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022426-002 | M-177 | 2019-04-05 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022426-003 | M-177 | 2019-04-05 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022426-004 | M-177 | 2019-04-05 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022426-005 | M-177 | 2019-04-05 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022426-006 | M-177 | 2019-04-05 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022426-001 | M-177 | 2019-04-05 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022426-002 | M-177 | 2019-04-05 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022426-003 | M-177 | 2019-04-05 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022426-004 | M-177 | 2019-04-05 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022426-005 | M-177 | 2019-04-05 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022426-006 | M-177 | 2019-04-05 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Alogliptin and Pioglitazone | ALOGLIPTIN BENZOATE AND PIOGLITAZONE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | 642b1e90-701e-42f2-bac6-a4918738e2c9 | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | 022426 NDA022426 45802-351 45802-260 45802-402 45802-499 |
| OSENI | ALOGLIPTIN AND PIOGLITAZONE | Takeda Pharmaceuticals America, Inc. | 4c619ed9-fe3e-4158-9938-80c6c3493d55 | 2025-02-28 | Boxed warning, Warnings, Adverse reactions | 022426 NDA022426 64764-254 64764-123 64764-251 64764-253 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-238 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-238 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-238 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-238 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-238 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-260 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-260 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-260 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-260 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-260 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-304 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-304 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-304 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-304 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-304 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-351 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-351 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-351 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-351 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-351 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-402 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-402 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-402 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-402 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-402 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-499 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-499 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-499 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 45802-499 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Padagis Israel Pharmaceuticals Ltd | NDA AUTHORIZED GENERIC | Current |
| 45802-499 | Alogliptin and Pioglitazone | Alogliptin Benzoate and Pioglitazone hydrochloride | Perrigo New York Inc | NDA AUTHORIZED GENERIC | Current |
| 64764-121 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-121 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-121 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-121 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-121 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-121 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-123 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-123 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-123 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-123 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-123 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-123 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-124 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-124 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-124 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-124 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-124 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-124 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-251 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-251 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-251 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-251 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-251 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-251 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-253 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-253 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-253 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-253 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-253 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-253 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-254 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-254 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-254 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-254 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-254 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-254 | OSENI | alogliptin and pioglitazone | Takeda Pharmaceuticals America, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78955 | SUPPL | 2024-07-02 |
| 78938 | SUPPL | 2024-07-01 |
| 78937 | SUPPL | 2024-07-01 |
| 70516 | SUPPL | 2022-03-15 |
| 70515 | SUPPL | 2022-03-15 |
| 70508 | SUPPL | 2022-03-14 |
| 59256 | SUPPL | 2019-07-05 |
| 59255 | SUPPL | 2019-07-05 |
| 59211 | SUPPL | 2019-07-02 |
| 50920 | SUPPL | 2017-12-27 |
| 50856 | SUPPL | 2017-12-26 |
| 46562 | SUPPL | 2016-12-27 |
| 46197 | SUPPL | 2016-12-19 |
| 46145 | SUPPL | 2016-12-14 |
| 46142 | SUPPL | 2016-12-13 |
| 38700 | SUPPL | 2016-04-07 |
| 7379 | SUPPL | 2016-04-07 |
| 17578 | SUPPL | 2015-09-21 |
| 29721 | SUPPL | 2015-09-01 |
| 22018 | ORIG | 2014-04-17 |
| 44503 | ORIG | 2013-02-12 |
| 29720 | ORIG | 2013-02-12 |
| 17577 | ORIG | 2013-02-12 |