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Boehringer Ingelheim
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Chinese Patent Office
Argus Health
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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078385

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NDA 078385 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 thirty-six 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-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
Summary for 078385
Pharmacology for NDA: 078385
Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 078385
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 078385 ANDA Unit Dose Services 50436-6665 N 50436-6665-3
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 078385 ANDA Unit Dose Services 50436-6665 N 50436-6665-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;50MG
Approval Date:Oct 6, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Oct 6, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cipla
Moodys
Teva
Harvard Business School
QuintilesIMS
Merck
Healthtrust
AstraZeneca

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