FdaApplication

ANDA 209242

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Identifiers

Properties

PropertyValue
applicant_nameHETERO LABS LTD UNIT V
application_typeANDA
approval_date2025-10-06

Products (5)

ProductActive ingredientStrengthDosage form
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;25MG;40MGTABLET;ORAL
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;12.5MG;40MGTABLET;ORAL
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;12.5MG;20MGTABLET;ORAL
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 10MG BASE;12.5MG;40MGTABLET;ORAL
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 10MG BASE;25MG;40MGTABLET;ORAL

5 products