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Generated: May 22, 2018

DrugPatentWatch Database Preview

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, Cadista Pharms, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Sandoz, Teva Pharms, Torrent Pharms, Unichem Labs Ltd, Watson Labs, West-ward Pharms Int, and Zydus Pharms Usa Inc, and is included in sixteen NDAs. It is available from forty-four 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. Forty-seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
Summary for 201845
Tradename:LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Applicant:Cadista Pharms
Ingredient:hydrochlorothiazide; losartan potassium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201845
Ingredient-typeThiazides
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 JUBILANT CADISTA PHARMACEUTICALS INC. 59746-337 N 59746-337-01
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 201845 ANDA JUBILANT CADISTA PHARMACEUTICALS INC. 59746-337 N 59746-337-10

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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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Boehringer Ingelheim
Chinese Patent Office
Cantor Fitzgerald
Baxter
Fish and Richardson
US Department of Justice
Citi
Federal Trade Commission

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