FdaApplication

ANDA 211779

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Identifiers

Properties

PropertyValue
applicant_nameALKEM LABORATORIES LTD
application_typeANDA
approval_date2019-10-04

Products (3)

ProductActive ingredientStrengthDosage form
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGTABLET;ORAL
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE20MGTABLET;ORAL
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE5MGTABLET;ORAL

3 products