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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 201845


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NDA 201845 describes LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Granules, Hikma, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Sandoz, Teva Pharms, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from thirty suppliers. Additional details are available on the LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 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.
Pharmacology for NDA: 201845
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 201845
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 201845 ANDA AvKARE 42291-502 42291-502-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-502-90)
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 201845 ANDA AvKARE 42291-503 42291-503-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-503-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;50MG
Approval Date:Sep 18, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;100MG
Approval Date:Sep 18, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Sep 18, 2012TE:ABRLD:No

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