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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 210552


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NDA 210552 describes OLMESARTAN MEDOXOMIL, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd V, Inventia, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Prinston Inc, Qilu, Rising, Sandoz, Sciegen Pharms Inc, Sunshine, Teva Pharms Usa, Torrent, Umedica, Zydus Pharms, Hangzhou Binjiang, Natco Pharma Usa, Ph Health, and Piramal, and is included in forty-five NDAs. It is available from twenty-nine suppliers. Additional details are available on the OLMESARTAN MEDOXOMIL profile page.

The generic ingredient in OLMESARTAN MEDOXOMIL 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 210552
Tradename:OLMESARTAN MEDOXOMIL
Applicant:Qilu
Ingredient:olmesartan medoxomil
Patents:0
Medical Subject Heading (MeSH) Categories for 210552

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 10, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jan 10, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jan 10, 2019TE:ABRLD:No

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