Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 205776
Company: MEDAC PHARMA INC
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
03/15/2018 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
03/15/2018 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English