Application 212884
- Type
- ANDA
- Sponsor
- AMNEAL
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 50MG ACID | No | No |
| 003 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 25MG 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 |
|---|---|---|---|---|---|---|---|
| A212884-001 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET / ORAL | AB | 2026-01-14 | |
| A212884-002 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET / ORAL | AB | 2026-01-14 | |
| A212884-003 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET / ORAL | AB | 2026-01-14 | |
| A212884-004 | ELTROMBOPAG OLAMINE | ELTROMBOPAG OLAMINE | EQ 75MG ACID | TABLET / ORAL | AB | 2026-01-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212884-001 | AB |
| A212884-002 | AB |
| A212884-003 | AB |
| A212884-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A212884-001 | ELTROMBOPAG OLAMINE | EQ 12.5MG ACID | TABLET / ORAL | AB | 2026-01-14 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A212884-002 | ELTROMBOPAG OLAMINE | EQ 50MG ACID | TABLET / ORAL | AB | 2026-01-14 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A212884-003 | ELTROMBOPAG OLAMINE | EQ 25MG ACID | TABLET / ORAL | AB | 2026-01-14 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A212884-004 | 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 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A212884-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A212884-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A212884-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A212884-004 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Eltrombopag Olamine | ELTROMBOPAG | AvKARE | 4af8f855-f710-e96f-e063-6294a90abb46 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 212884 ANDA212884 |
| Eltrombopag Olamine | ELTROMBOPAG | Amneal Pharmaceuticals NY LLC | c97337c3-d758-40a3-a1ef-fd122f15e821 | 2025-11-20 | Boxed warning, Warnings, Adverse reactions | 212884 ANDA212884 |
| Eltrombopag Olamine | ELTROMBOPAG | Amneal Pharmaceuticals NY LLC | 05acf38e-7870-4809-a045-fc38e66b1110 | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | 212884 ANDA212884 |