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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091629

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NDA 091629 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-two 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-one drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.

Summary for 091629

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 091629

Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 091629

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 091629 ANDA NorthStar Rx LLC 16714-224 16714-224-03 1000 TABLET, FILM COATED in 1 BOTTLE (16714-224-03)
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; losartan potassium TABLET;ORAL 091629 ANDA NorthStar Rx LLC 16714-224 16714-224-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-224-01)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;100MG
Approval Date:Oct 6, 2010TE:ABRLD:No

Summary for product number 003

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


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US Department of Justice
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Baxter

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