FdaApplication

ANDA 209404

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Identifiers

Properties

PropertyValue
applicant_nameMACLEODS PHARMACEUTICALS LTD
application_typeANDA
approval_date2025-01-31

Products (3)

ProductActive ingredientStrengthDosage form
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE;ORAL
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE;ORAL
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE;ORAL

3 products