Details for New Drug Application (NDA): 206631

NDA 206631 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 206631

Tradename:	OLMESARTAN MEDOXOMIL
Applicant:	Lupin Ltd
Ingredient:	olmesartan medoxomil
Patents:	0

Medical Subject Heading (MeSH) Categories for 206631

Angiotensin II Type 1 Receptor Blockers

Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 27, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Apr 27, 2017	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Apr 27, 2017	TE:		RLD:	No

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