Application 216774
- Type
- NDA
- Sponsor
- TEVA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALVAIZ | ELTROMBOPAG | TABLET; ORAL | 9MG | No | No |
| 002 | ALVAIZ | ELTROMBOPAG | TABLET; ORAL | 18MG | No | No |
| 003 | ALVAIZ | ELTROMBOPAG | TABLET; ORAL | 36MG | No | No |
| 004 | ALVAIZ | ELTROMBOPAG | TABLET;ORAL | 54MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216774-001 | ALVAIZ | ELTROMBOPAG CHOLINE | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | |
| N216774-002 | ALVAIZ | ELTROMBOPAG CHOLINE | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | |
| N216774-003 | ALVAIZ | ELTROMBOPAG CHOLINE | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | |
| N216774-004 | ALVAIZ | ELTROMBOPAG CHOLINE | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216774-001 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 |
| N216774-001 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 |
| N216774-001 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 |
| N216774-002 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 |
| N216774-002 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 |
| N216774-002 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 |
| N216774-003 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 |
| N216774-003 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 |
| N216774-003 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 |
| N216774-004 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 |
| N216774-004 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 |
| N216774-004 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 |
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 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216774-001 | ALVAIZ | EQ 9MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216774-002 | ALVAIZ | EQ 18MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216774-003 | ALVAIZ | EQ 36MG BASE | TABLET / ORAL | RLD | 2023-11-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N216774-004 | ALVAIZ | EQ 54MG BASE | TABLET / ORAL | RLD, RS | 2023-11-29 | d06236e962d9… |
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 | N216774-001 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-001 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-001 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-002 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-002 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-002 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-003 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-003 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-003 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-004 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-004 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216774-004 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-001 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-001 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-001 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-002 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-002 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-002 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-003 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-003 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-003 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-004 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-004 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216774-004 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-001 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-001 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-001 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-002 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-002 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-002 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-003 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-003 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-003 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-004 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-004 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216774-004 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-001 | 11072586 | 2038-11-05 | U-3936 | Drug substance, Drug product | 2024-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-001 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-001 | 11072586 | 2038-11-05 | U-3938 | Drug substance, Drug product | 2024-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216774-002 | 11072586 | 2038-11-05 | U-3937 | Drug substance, Drug product | 2024-05-22 | fd3edfee7708… |
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 |
|---|---|---|---|---|---|---|
| ALVAIZ | ELTROMBOPAG | Teva Pharmaceuticals, Inc. | ed51e463-7a03-4858-bbd2-882ce4753d5a | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | 216774 NDA216774 |