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Last Updated: January 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211049

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NDA 211049 describes OLMESARTAN MEDOXOMIL, which is a drug marketed by Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Mylan, Qilu, Sciegen Pharms Inc, Sunshine Lake, Teva Pharms Usa, Torrent, Umedica Labs Pvt Ltd, Zydus Pharms, Prinston Inc, and Par Pharm Inc, and is included in twenty-eight NDAs. It is available from twenty-two 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 211049
Tradename:OLMESARTAN MEDOXOMIL
Applicant:Sunshine Lake
Ingredient:olmesartan medoxomil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211049
Medical Subject Heading (MeSH) Categories for 211049
Suppliers and Packaging for NDA: 211049
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 211049 ANDA Sunshine Lake Pharma Co., Ltd. 48792-7877 48792-7877-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7877-1)
OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 211049 ANDA Sunshine Lake Pharma Co., Ltd. 48792-7878 48792-7878-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (48792-7878-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 22, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Feb 22, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Feb 22, 2019TE:ABRLD:No

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