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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 207135


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NDA 207135 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 207135
Tradename:OLMESARTAN MEDOXOMIL
Applicant:Umedica
Ingredient:olmesartan medoxomil
Patents:0
Pharmacology for NDA: 207135
Medical Subject Heading (MeSH) Categories for 207135
Suppliers and Packaging for NDA: 207135
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 207135 ANDA Lifestar Pharma LLC 70756-808 70756-808-30 30 TABLET in 1 BOTTLE (70756-808-30)
OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 207135 ANDA Lifestar Pharma LLC 70756-808 70756-808-90 90 TABLET in 1 BOTTLE (70756-808-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 18, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jul 18, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jul 18, 2019TE:ABRLD:No

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