FdaApplication

ANDA 211545

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Identifiers

Properties

PropertyValue
applicant_nameALKEM LABORATORIES LTD
application_typeANDA
approval_date2026-04-06

Products (2)

ProductActive ingredientStrengthDosage form
DAPAGLIFLOZINDAPAGLIFLOZIN5MGTABLET;ORAL
DAPAGLIFLOZINDAPAGLIFLOZIN10MGTABLET;ORAL

2 products