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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59137-505 | Rasuvo | methotrexate | Medac Pharma, Inc | NDA | Current |
| 59137-505 | Rasuvo | methotrexate | Medexus 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 | Medac Pharma, Inc | NDA | Current |
| 59137-525 | Rasuvo | methotrexate | Medexus 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 |