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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 209242


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NDA 209242 describes OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Hetero Labs Ltd V, Macleods Pharms Ltd, Ph Health, Piramal, Teva Pharms Usa, and Torrent, and is included in six NDAs. It is available from six suppliers. Additional details are available on the OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE is amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil. There are fifty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 209242
Tradename:OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Applicant:Hetero Labs Ltd V
Ingredient:amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;12.5MG;20MG
Approval Date:Oct 6, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;12.5MG;40MG
Approval Date:Oct 6, 2025TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;25MG;40MG
Approval Date:Oct 6, 2025TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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