← FDA DRUG APPROVALS

FDA NDA · NDA205776

RASUVO

methotrexate

Sponsor: MEDEXUS

APPLICATION
NDA205776
TYPE
NDA
ORIGINAL APPROVAL
2014-07-10
LATEST ACTION
2020-03-11
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

RASUVO · ReferenceDiscontinued
METHOTREXATE 27.5MG/0.55ML (27.5MG/0.55ML) · SOLUTION · SUBCUTANEOUS
RASUVO · ReferencePrescription
METHOTREXATE 22.5MG/0.45ML (22.5MG/0.45ML) · SOLUTION · SUBCUTANEOUS
RASUVO · ReferencePrescription
METHOTREXATE 17.5MG/0.35ML (17.5MG/0.35ML) · SOLUTION · SUBCUTANEOUS
RASUVO · ReferencePrescription
METHOTREXATE 12.5MG/0.25ML (12.5MG/0.25ML) · SOLUTION · SUBCUTANEOUS
RASUVO · ReferencePrescription
METHOTREXATE 7.5MG/0.15ML (7.5MG/0.15ML) · SOLUTION · SUBCUTANEOUS
RASUVO · ReferencePrescription
METHOTREXATE 25MG/0.5ML (25MG/0.5ML) · SOLUTION · SUBCUTANEOUS
RASUVO · ReferencePrescription
METHOTREXATE 20MG/0.4ML (20MG/0.4ML) · SOLUTION · SUBCUTANEOUS
RASUVO · ReferencePrescription
METHOTREXATE 15MG/0.30ML (15MG/0.30ML) · SOLUTION · SUBCUTANEOUS
RASUVO · ReferencePrescription
METHOTREXATE 30MG/0.6ML (30MG/0.6ML) · SOLUTION · SUBCUTANEOUS
RASUVO · ReferencePrescription
METHOTREXATE 10MG/0.20ML (10MG/0.20ML) · SOLUTION · SUBCUTANEOUS

Approval history

2020-03-11Labeling · Supplement 4 · standard — Letter ↗AP
2018-03-15Labeling · Supplement 2 · standard — Label ↗AP
2015-08-24Labeling · Supplement 1 · standard — Letter ↗AP
2014-07-10Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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