Application 205776
- Type
- NDA
- Sponsor
- MEDEXUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RASUVO | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 7.5MG/0.15ML (7.5MG/0.15ML) | Yes | Yes |
| 002 | RASUVO | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 10MG/0.20ML (10MG/0.20ML) | Yes | Yes |
| 003 | RASUVO | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 12.5MG/0.25ML (12.5MG/0.25ML) | Yes | Yes |
| 004 | RASUVO | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 15MG/0.30ML (15MG/0.30ML) | Yes | Yes |
| 005 | RASUVO | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 17.5MG/0.35ML (17.5MG/0.35ML) | Yes | Yes |
| 006 | RASUVO | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 20MG/0.4ML (20MG/0.4ML) | Yes | Yes |
| 007 | RASUVO | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 22.5MG/0.45ML (22.5MG/0.45ML) | Yes | Yes |
| 008 | RASUVO | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 25MG/0.5ML (25MG/0.5ML) | Yes | Yes |
| 009 | RASUVO | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 27.5MG/0.55ML (27.5MG/0.55ML) | Yes | No |
| 010 | RASUVO | METHOTREXATE | SOLUTION;SUBCUTANEOUS | 30MG/0.6ML (30MG/0.6ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205776-001 | RASUVO | METHOTREXATE | 7.5MG/0.15ML (7.5MG/0.15ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | |
| N205776-002 | RASUVO | METHOTREXATE | 10MG/0.20ML (10MG/0.20ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | |
| N205776-003 | RASUVO | METHOTREXATE | 12.5MG/0.25ML (12.5MG/0.25ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | |
| N205776-004 | RASUVO | METHOTREXATE | 15MG/0.30ML (15MG/0.30ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | |
| N205776-005 | RASUVO | METHOTREXATE | 17.5MG/0.35ML (17.5MG/0.35ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | |
| N205776-006 | RASUVO | METHOTREXATE | 20MG/0.4ML (20MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | |
| N205776-007 | RASUVO | METHOTREXATE | 22.5MG/0.45ML (22.5MG/0.45ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | |
| N205776-008 | RASUVO | METHOTREXATE | 25MG/0.5ML (25MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | |
| N205776-009 | RASUVO | METHOTREXATE | 27.5MG/0.55ML (27.5MG/0.55ML) | SOLUTION / SUBCUTANEOUS | RLD | 2014-07-10 | |
| N205776-010 | RASUVO | METHOTREXATE | 30MG/0.6ML (30MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N205776-001 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | |
| N205776-002 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | |
| N205776-003 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | |
| N205776-004 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | |
| N205776-005 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | |
| N205776-006 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | |
| N205776-007 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | |
| N205776-008 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | |
| N205776-009 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | |
| N205776-010 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 |
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 | N205776-001 | RASUVO | 7.5MG/0.15ML (7.5MG/0.15ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-002 | RASUVO | 10MG/0.20ML (10MG/0.20ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-003 | RASUVO | 12.5MG/0.25ML (12.5MG/0.25ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-004 | RASUVO | 15MG/0.30ML (15MG/0.30ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-005 | RASUVO | 17.5MG/0.35ML (17.5MG/0.35ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-006 | RASUVO | 20MG/0.4ML (20MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-007 | RASUVO | 22.5MG/0.45ML (22.5MG/0.45ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-008 | RASUVO | 25MG/0.5ML (25MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-009 | RASUVO | 27.5MG/0.55ML (27.5MG/0.55ML) | SOLUTION / SUBCUTANEOUS | RLD | 2014-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-010 | RASUVO | 30MG/0.6ML (30MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-001 | RASUVO | 7.5MG/0.15ML (7.5MG/0.15ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-002 | RASUVO | 10MG/0.20ML (10MG/0.20ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-003 | RASUVO | 12.5MG/0.25ML (12.5MG/0.25ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-004 | RASUVO | 15MG/0.30ML (15MG/0.30ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-005 | RASUVO | 17.5MG/0.35ML (17.5MG/0.35ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-006 | RASUVO | 20MG/0.4ML (20MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-007 | RASUVO | 22.5MG/0.45ML (22.5MG/0.45ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-008 | RASUVO | 25MG/0.5ML (25MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-009 | RASUVO | 27.5MG/0.55ML (27.5MG/0.55ML) | SOLUTION / SUBCUTANEOUS | RLD | 2014-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-010 | RASUVO | 30MG/0.6ML (30MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-001 | RASUVO | 7.5MG/0.15ML (7.5MG/0.15ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-002 | RASUVO | 10MG/0.20ML (10MG/0.20ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-003 | RASUVO | 12.5MG/0.25ML (12.5MG/0.25ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-004 | RASUVO | 15MG/0.30ML (15MG/0.30ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-005 | RASUVO | 17.5MG/0.35ML (17.5MG/0.35ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-006 | RASUVO | 20MG/0.4ML (20MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-007 | RASUVO | 22.5MG/0.45ML (22.5MG/0.45ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-008 | RASUVO | 25MG/0.5ML (25MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-009 | RASUVO | 27.5MG/0.55ML (27.5MG/0.55ML) | SOLUTION / SUBCUTANEOUS | RLD | 2014-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-010 | RASUVO | 30MG/0.6ML (30MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-001 | RASUVO | 7.5MG/0.15ML (7.5MG/0.15ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-002 | RASUVO | 10MG/0.20ML (10MG/0.20ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-003 | RASUVO | 12.5MG/0.25ML (12.5MG/0.25ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-004 | RASUVO | 15MG/0.30ML (15MG/0.30ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-005 | RASUVO | 17.5MG/0.35ML (17.5MG/0.35ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-006 | RASUVO | 20MG/0.4ML (20MG/0.4ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-007 | RASUVO | 22.5MG/0.45ML (22.5MG/0.45ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-008 | RASUVO | 25MG/0.5ML (25MG/0.5ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-009 | RASUVO | 27.5MG/0.55ML (27.5MG/0.55ML) | SOLUTION / SUBCUTANEOUS | RLD | 2014-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-010 | RASUVO | 30MG/0.6ML (30MG/0.6ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2014-07-10 | fd3edfee7708… |
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 | N205776-001 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-002 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-003 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-004 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-005 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-006 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-007 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-008 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-009 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205776-010 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-001 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-002 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-003 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-004 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-005 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-006 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-007 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-008 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-009 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205776-010 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-001 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-002 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-003 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-004 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-005 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-006 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-007 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-008 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-009 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205776-010 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-001 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-002 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-003 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-004 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-005 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-006 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-007 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-008 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-009 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205776-010 | 8664231 | 2029-06-01 | U-1442 | 2014-07-31 | 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 |
|---|---|---|---|---|---|---|
| Rasuvo | METHOTREXATE | Medexus Pharma Inc. | d0075461-0e7e-4967-9c9b-d6440e912c0e | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | 205776 NDA205776 59137-515 59137-530 59137-520 59137-510 59137-505 59137-535 59137-540 59137-525 59137-550 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59137-505 | Rasuvo | methotrexate | Medexus Pharma Inc. | NDA | Current |
| 59137-505 | Rasuvo | methotrexate | Medac Pharma, Inc | NDA | Current |
| 59137-510 | Rasuvo | methotrexate | Medexus Pharma Inc. | NDA | Current |
| 59137-510 | Rasuvo | methotrexate | Medac Pharma, Inc | NDA | Current |
| 59137-515 | Rasuvo | methotrexate | Medexus Pharma Inc. | NDA | Current |
| 59137-515 | Rasuvo | methotrexate | Medac Pharma, Inc | NDA | Current |
| 59137-520 | Rasuvo | methotrexate | Medexus Pharma Inc. | NDA | Current |
| 59137-520 | Rasuvo | methotrexate | Medac Pharma, Inc | NDA | Current |
| 59137-525 | Rasuvo | methotrexate | Medexus Pharma Inc. | NDA | Current |
| 59137-525 | Rasuvo | methotrexate | Medac Pharma, Inc | NDA | Current |
| 59137-530 | Rasuvo | methotrexate | Medexus Pharma Inc. | NDA | Current |
| 59137-530 | Rasuvo | methotrexate | Medac Pharma, Inc | NDA | Current |
| 59137-535 | Rasuvo | methotrexate | Medexus Pharma Inc. | NDA | Current |
| 59137-535 | Rasuvo | methotrexate | Medac Pharma, Inc | NDA | Current |
| 59137-540 | Rasuvo | methotrexate | Medexus Pharma Inc. | NDA | Current |
| 59137-540 | Rasuvo | methotrexate | Medac Pharma, Inc | NDA | Current |
| 59137-550 | Rasuvo | methotrexate | Medexus Pharma Inc. | NDA | Current |
| 59137-550 | Rasuvo | methotrexate | Medac Pharma, Inc | NDA | Current |