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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202375


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NDA 202375 describes OLMESARTAN MEDOXOMIL, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Breckenridge, Glenmark Pharms Ltd, 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, Natco Pharma Usa, and Par Pharm Inc, and is included in thirty-six NDAs. It is available from twenty-six 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 202375
Tradename:OLMESARTAN MEDOXOMIL
Applicant:Torrent
Ingredient:olmesartan medoxomil
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202375

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Apr 24, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Apr 24, 2017TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG
Approval Date:Apr 24, 2017TE:RLD:No

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