Application 216281
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216281-001 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET / ORAL | AB | 2026-01-14 | |
| A216281-002 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET / ORAL | AB | 2026-01-14 | |
| A216281-003 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET / ORAL | AB | 2026-01-14 | |
| A216281-004 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET / ORAL | AB | 2026-01-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216281-001 | AB |
| A216281-002 | AB |
| A216281-003 | AB |
| A216281-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A216281-001 | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET / ORAL | AB | 2026-01-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216281-002 | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET / ORAL | AB | 2026-01-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216281-003 | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET / ORAL | AB | 2026-01-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216281-004 | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET / ORAL | AB | 2026-01-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216281-001 | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET / ORAL | AB | 2026-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216281-002 | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET / ORAL | AB | 2026-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216281-003 | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET / ORAL | AB | 2026-01-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216281-004 | 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 | A216281-001 | 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 | A216281-002 | 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 | A216281-003 | 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 | A216281-004 | 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 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A216281-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216281-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216281-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216281-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A216281-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216281-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216281-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216281-004 | AB | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216281-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216281-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216281-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216281-004 | 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 | ELTROMBOPAG | Zydus Pharmaceuticals USA Inc. | 1cfdd1fa-d687-41f9-a160-9491f0beac1e | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | 216281 ANDA216281 |
| ELTROMBOPAG | ELTROMBOPAG | Zydus Lifesciences Limited | ae9a7725-64f8-406d-88e7-e6e01136deae | 2026-01-14 | 216281 ANDA216281 |