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Last Updated: May 14, 2021

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Details for New Drug Application (NDA): 090544

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NDA 090544 describes LOSARTAN POTASSIUM, which is a drug marketed by Alembic Pharms Ltd, Apotex Corp, Aurobindo Pharma, Cadista Pharms, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Mylan, Prinston Inc, Sandoz, Strides Pharma, Teva, Torrent Pharms, Unichem, Upsher Smith Labs, Watson Labs, Zydus Pharms Usa Inc, Apotex, and Teva Pharms, and is included in thirty-seven NDAs. It is available from fifty suppliers. Additional details are available on the LOSARTAN POTASSIUM profile page.

The generic ingredient in LOSARTAN POTASSIUM is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
Summary for 090544
Tradename:LOSARTAN POTASSIUM
Applicant:Upsher Smith Labs
Ingredient:losartan potassium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 090544

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Oct 6, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 6, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Oct 6, 2010TE:ABRLD:No

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