FdaApplication

ANDA 220315

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Identifiers

Properties

PropertyValue
applicant_nameDR REDDYS LABORATORIES LTD
application_typeANDA
approval_date2026-02-25

Products (2)

ProductActive ingredientStrengthDosage form
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)INJECTABLE;INJECTION
DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)INJECTABLE;INJECTION

2 products