FdaApplication

NDA 208574

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Identifiers

Properties

PropertyValue
applicant_nameTEVA PHARMACEUTICALS USA INC
application_typeNDA
approval_date2020-03-13

Products (2)

ProductActive ingredientStrengthDosage form
ROMIDEPSINROMIDEPSIN10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION;INTRAVENOUS
ROMIDEPSINROMIDEPSIN27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION;INTRAVENOUS

2 products