Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205776
Company: MEDEXUS
Company: MEDEXUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RASUVO | METHOTREXATE | 7.5MG/0.15ML (7.5MG/0.15ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
RASUVO | METHOTREXATE | 10MG/0.20ML (10MG/0.20ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
RASUVO | METHOTREXATE | 12.5MG/0.25ML (12.5MG/0.25ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
RASUVO | METHOTREXATE | 15MG/0.30ML (15MG/0.30ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
RASUVO | METHOTREXATE | 17.5MG/0.35ML (17.5MG/0.35ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
RASUVO | METHOTREXATE | 20MG/0.4ML (20MG/0.4ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
RASUVO | METHOTREXATE | 22.5MG/0.45ML (22.5MG/0.45ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
RASUVO | METHOTREXATE | 25MG/0.5ML (25MG/0.5ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
RASUVO | METHOTREXATE | 27.5MG/0.55ML (27.5MG/0.55ML) | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | No |
RASUVO | METHOTREXATE | 30MG/0.6ML (30MG/0.6ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/10/2014 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205776s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205776Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205776Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/11/2020 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205776s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205776Orig1s004ltr.pdf | |
03/15/2018 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205776s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205776Orig1s002ltr.pdf | |
08/24/2015 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205776s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205776Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/11/2020 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205776s004lbl.pdf | |
03/15/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205776s002lbl.pdf | |
08/24/2015 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205776s001lbl.pdf | |
07/10/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205776s000lbl.pdf |