FdaApplication

NDA 205776

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Identifiers

Properties

PropertyValue
applicant_nameMEDEXUS PHARMA INC
application_typeNDA
approval_date2014-07-10

Products (10)

ProductActive ingredientStrengthDosage form
RASUVOMETHOTREXATE27.5MG/0.55ML (27.5MG/0.55ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION;SUBCUTANEOUS
RASUVOMETHOTREXATE12.5MG/0.25ML (12.5MG/0.25ML)SOLUTION;SUBCUTANEOUS
RASUVOMETHOTREXATE22.5MG/0.45ML (22.5MG/0.45ML)SOLUTION;SUBCUTANEOUS
RASUVOMETHOTREXATE17.5MG/0.35ML (17.5MG/0.35ML)SOLUTION;SUBCUTANEOUS
RASUVOMETHOTREXATE15MG/0.30ML (15MG/0.30ML)SOLUTION;SUBCUTANEOUS
RASUVOMETHOTREXATE20MG/0.4ML (20MG/0.4ML)SOLUTION;SUBCUTANEOUS
RASUVOMETHOTREXATE25MG/0.5ML (25MG/0.5ML)SOLUTION;SUBCUTANEOUS
RASUVOMETHOTREXATE10MG/0.20ML (10MG/0.20ML)SOLUTION;SUBCUTANEOUS
RASUVOMETHOTREXATE7.5MG/0.15ML (7.5MG/0.15ML)SOLUTION;SUBCUTANEOUS
RASUVOMETHOTREXATE30MG/0.6ML (30MG/0.6ML)SOLUTION;SUBCUTANEOUS

10 products