Application 219638
- Type
- ANDA
- Sponsor
- SOMERSET THERAPS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 12.5MG ACID | No | No |
| 002 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 25MG ACID | No | No |
| 003 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 50MG ACID | No | No |
| 004 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 75MG ACID | No | No |
| 005 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | TABLET | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219638-001 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET / ORAL | AB | 2026-01-14 | |
| A219638-002 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET / ORAL | AB | 2026-01-14 | |
| A219638-003 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET / ORAL | AB | 2026-01-14 | |
| A219638-004 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET / ORAL | AB | 2026-01-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219638-001 | AB |
| A219638-002 | AB |
| A219638-003 | AB |
| A219638-004 | AB |
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 | A219638-001 | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET / ORAL | AB | 2026-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219638-002 | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET / ORAL | AB | 2026-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219638-003 | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET / ORAL | AB | 2026-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219638-004 | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET / ORAL | AB | 2026-01-14 | 011fe1cb6892… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219638-001 | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET / ORAL | AB | 2026-01-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219638-002 | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET / ORAL | AB | 2026-01-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219638-003 | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET / ORAL | AB | 2026-01-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219638-004 | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET / ORAL | AB | 2026-01-14 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219638-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219638-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219638-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219638-004 | AB | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219638-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219638-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219638-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219638-004 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Eltrombopag olamine | ELTROMBOPAG OLAMINE | Amerisyn, LLC | 52ba8e06-aa7d-caa6-e063-6294a90a5ce5 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 219638 ANDA219638 |
| Eltrombopag olamine | ELTROMBOPAG OLAMINE | Somerset Therapeutics, LLC | 604f663c-4933-402a-8105-5921713cf3c8 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | 219638 ANDA219638 |