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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205776
Company: MEDEXUS

Products on NDA 205776

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205776

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

Labels for NDA 205776

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

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