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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 206720


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NDA 206720 describes OLMESARTAN MEDOXOMIL, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Chartwell Rx, 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 Endo Operations, and is included in thirty-six NDAs. It is available from twenty-eight 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. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 206720
Tradename:OLMESARTAN MEDOXOMIL
Applicant:Prinston Inc
Ingredient:olmesartan medoxomil
Patents:0
Pharmacology for NDA: 206720
Medical Subject Heading (MeSH) Categories for 206720
Suppliers and Packaging for NDA: 206720
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 206720 ANDA Solco Healthcare US, LLC. 43547-299 43547-299-03 30 TABLET in 1 BOTTLE (43547-299-03)
OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 206720 ANDA Solco Healthcare US, LLC. 43547-299 43547-299-09 90 TABLET in 1 BOTTLE (43547-299-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 2, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 2, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Dec 2, 2022TE:ABRLD:No

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