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Details for New Drug Application (NDA): 078232

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NDA 078232 describes LOSARTAN POTASSIUM, which is a drug marketed by Sandoz, Alembic Pharms Ltd, Watson Labs, Macleods Pharms Ltd, Unichem Labs Ltd, Lupin Ltd, Hetero Labs Ltd V, Micro Labs Ltd India, Zydus Pharms Usa Inc, Upsher Smith, Teva, Roxane, Torrent Pharms, Cadista Pharms, Vivimed Labs, Aurobindo Pharma, Apotex Corp, Ipca Labs Ltd, Mylan, Prinston Inc, Apotex, and Teva Pharms, and is included in thirty-four NDAs. It is available from sixty-six suppliers. Additional details are available on the LOSARTAN POTASSIUM profile page.

The generic ingredient in LOSARTAN POTASSIUM 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: 078232

Lupin Ltd
losartan potassium
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078232

Suppliers and Packaging for NDA: 078232

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
losartan potassium
TABLET;ORAL 078232 ANDA Lupin Pharmaceuticals, Inc. 68180-210 68180-210-01 100 TABLET in 1 BOTTLE (68180-210-01)
losartan potassium
TABLET;ORAL 078232 ANDA Lupin Pharmaceuticals, Inc. 68180-210 68180-210-03 1000 TABLET in 1 BOTTLE (68180-210-03)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Oct 6, 2010TE:BXRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Oct 6, 2010TE:BXRLD:No

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