FdaApplication

ANDA 208040

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Identifiers

Properties

PropertyValue
applicant_nameALKEM LABORATORIES LTD
application_typeANDA
approval_date2020-03-11

Products (3)

ProductActive ingredientStrengthDosage form
DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE;ORAL
DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE;ORAL
DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE;ORAL

3 products