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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203835

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NDA 203835 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 Labs, Teva, West-ward Pharms Int, 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-seven 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-five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.

Summary for NDA: 203835

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203835

Suppliers and Packaging for NDA: 203835

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOSARTAN POTASSIUM
losartan potassium
TABLET;ORAL 203835 ANDA Camber Pharmaceuticals, Inc. 31722-700 31722-700-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-700-05)
LOSARTAN POTASSIUM
losartan potassium
TABLET;ORAL 203835 ANDA Camber Pharmaceuticals, Inc. 31722-700 31722-700-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-700-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Aug 12, 2015TE:BXRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 12, 2015TE:BXRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 12, 2015TE:BXRLD:No


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