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Last Updated: April 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206515


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NDA 206515 describes OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Accord Hlthcare, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Mylan, Prinston Inc, Teva Pharms Usa, Torrent, and Umedica Labs Pvt Ltd, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 206515
Pharmacology for NDA: 206515
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 206515
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 206515 ANDA TORRENT PHARMACEUTICALS LIMITED 13668-251 13668-251-01 1000 TABLET in 1 BOTTLE (13668-251-01)
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 206515 ANDA TORRENT PHARMACEUTICALS LIMITED 13668-251 13668-251-30 30 TABLET in 1 BOTTLE (13668-251-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:May 3, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;40MG
Approval Date:May 3, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;40MG
Approval Date:May 3, 2017TE:ABRLD:No

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