FdaApplication

ANDA 206156

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Identifiers

Properties

PropertyValue
applicant_nameMACLEODS PHARMACEUTICALS LTD
application_typeANDA
approval_date2016-06-24

Products (7)

ProductActive ingredientStrengthDosage form
PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET, EXTENDED RELEASE;ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET, EXTENDED RELEASE;ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE3.75MGTABLET, EXTENDED RELEASE;ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE4.5MGTABLET, EXTENDED RELEASE;ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE3MGTABLET, EXTENDED RELEASE;ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE2.25MGTABLET, EXTENDED RELEASE;ORAL
PRAMIPEXOLE DIHYDROCHLORIDEPRAMIPEXOLE DIHYDROCHLORIDE0.375MGTABLET, EXTENDED RELEASE;ORAL

7 products