FdaApplication

ANDA 200737

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Identifiers

Properties

PropertyValue
applicant_nameALKEM LABORATORIES LTD
application_typeANDA
approval_date2012-12-07

Products (4)

ProductActive ingredientStrengthDosage form
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE10MGTABLET;ORAL
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE50MGTABLET;ORAL
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE25MGTABLET;ORAL
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE100MGTABLET;ORAL

4 products