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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 203580


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NDA 203580 describes OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Hetero Labs Ltd V, Macleods Pharms Ltd, Micro Labs, Ph Health, Piramal, Teva Pharms Usa, and Torrent, and is included in seven NDAs. It is available from eight 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. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 203580
Tradename:OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Applicant:Torrent
Ingredient:amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE;12.5MG;20MG
Approval Date:Oct 26, 2016TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;12.5MG;40MG
Approval Date:Oct 26, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;25MG;40MG
Approval Date:Oct 26, 2016TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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