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Generated: May 29, 2017

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Details for New Drug Application (NDA): 077732

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NDA 077732 describes LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Torrent Pharms, Aurobindo Pharma, West-ward Pharms Int, Cadista Pharms, Lupin Ltd, Sandoz, Apotex, Mylan, Teva Pharms, Watson Labs, Ipca Labs Ltd, Zydus Pharms Usa Inc, and Macleods Pharms Ltd, and is included in fourteen 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 NDA: 077732

Formulation / Manufacturing:see details

Pharmacology for NDA: 077732

Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 077732

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrochlorothiazide; losartan potassium
TABLET;ORAL 077732 ANDA West-Ward Pharmaceuticals Corp. 0054-0126 0054-0126-22 90 TABLET in 1 BOTTLE (0054-0126-22)
hydrochlorothiazide; losartan potassium
TABLET;ORAL 077732 ANDA West-Ward Pharmaceuticals Corp. 0054-0127 0054-0127-22 90 TABLET in 1 BOTTLE (0054-0127-22)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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