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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, Torrent Pharms, Aurobindo Pharma, Roxane, 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-three 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-six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.

Summary for NDA: 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 59746-337-01 100 TABLET, FILM COATED in 1 BOTTLE (59746-337-01)
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; losartan potassium
TABLET;ORAL 201845 ANDA JUBILANT CADISTA PHARMACEUTICALS, INC. 59746-337 59746-337-10 1000 TABLET, FILM COATED in 1 BOTTLE (59746-337-10)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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