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Last Updated: February 24, 2021

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Details for New Drug Application (NDA): 203580

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NDA 203580 describes OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Par Pharm Inc, Teva Pharms Usa, and Torrent, and is included in three NDAs. It is available from four suppliers. Additional details are available on the OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 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.
Pharmacology for NDA: 203580
Suppliers and Packaging for NDA: 203580
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 203580 ANDA Torrent Pharmaceuticals Limited 13668-382 13668-382-05 500 TABLET in 1 BOTTLE (13668-382-05)
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 203580 ANDA Torrent Pharmaceuticals Limited 13668-382 13668-382-30 30 TABLET in 1 BOTTLE (13668-382-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;12.5MG;20MG
Approval Date:Oct 26, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;12.5MG;40MG
Approval Date:Oct 26, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;25MG;40MG
Approval Date:Oct 26, 2016TE:ABRLD:No

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