Application 217585
- Type
- ANDA
- Sponsor
- MSN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLUMIANT | BARICITINIB | TABLET;ORAL | 1MG | No | No |
| 002 | OLUMIANT | BARICITINIB | TABLET;ORAL | 2MG | No | No |
| 003 | OLUMIANT | BARICITINIB | TABLET;ORAL | 4MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217585-001 | OLUMIANT | BARICITINIB | 1MG | TABLET / ORAL | AB | 2025-08-08 | |
| A217585-002 | OLUMIANT | BARICITINIB | 2MG | TABLET / ORAL | AB | 2025-08-08 | |
| A217585-003 | OLUMIANT | BARICITINIB | 4MG | TABLET / ORAL | AB | 2025-08-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217585-001 | AB |
| A217585-002 | AB |
| A217585-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217585-001 | OLUMIANT | 1MG | TABLET / ORAL | AB | 2025-08-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217585-002 | OLUMIANT | 2MG | TABLET / ORAL | AB | 2025-08-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217585-003 | OLUMIANT | 4MG | TABLET / ORAL | AB | 2025-08-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A217585-001 | OLUMIANT | 1MG | TABLET / ORAL | AB | 2025-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217585-002 | OLUMIANT | 2MG | TABLET / ORAL | AB | 2025-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217585-003 | OLUMIANT | 4MG | TABLET / ORAL | AB | 2025-08-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217585-001 | OLUMIANT | 1MG | TABLET / ORAL | AB | 2025-08-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217585-002 | OLUMIANT | 2MG | TABLET / ORAL | AB | 2025-08-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217585-003 | OLUMIANT | 4MG | TABLET / ORAL | AB | 2025-08-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217585-001 | OLUMIANT | 1MG | TABLET / ORAL | AB | 2025-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217585-002 | OLUMIANT | 2MG | TABLET / ORAL | AB | 2025-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217585-003 | OLUMIANT | 4MG | TABLET / ORAL | AB | 2025-08-08 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217585-001 | OLUMIANT | 1MG | TABLET / ORAL | AB | 2025-08-08 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217585-002 | OLUMIANT | 2MG | TABLET / ORAL | AB | 2025-08-08 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217585-003 | OLUMIANT | 4MG | TABLET / ORAL | AB | 2025-08-08 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217585-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217585-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217585-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A217585-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217585-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217585-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217585-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217585-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217585-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217585-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217585-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217585-003 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217585-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217585-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217585-003 | 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 |
|---|---|---|---|---|---|---|
| Olumiant | BARICITINIB | Eli Lilly and Company | 866e9f35-9035-4581-a4b1-75a621ab55cf | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | Olumiant BARICITINIB |
| Baricitinib | BARICITINIB | Eli Lilly and Company | 7052c055-fedf-453b-86bc-01f5465eb157 | 2022-05-10 | BARICITINIB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.