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Queensland Health
Chinese Patent Office
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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078243

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NDA 078243 describes LOSARTAN POTASSIUM, which is a drug marketed by Alembic Pharms Ltd, Apotex Corp, Aurobindo Pharma, Cadista Pharms, Hetero Labs Ltd V, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Sandoz, Teva, Torrent Pharms, Unichem Labs Ltd, Upsher-smith Labs, Viva Hlthcare, Vivimed Global, Watson Labs, West-ward Pharms Int, Zydus Pharms Usa Inc, Apotex, and Teva Pharms, and is included in thirty-six 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-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
Summary for 078243
Tradename:LOSARTAN POTASSIUM
Applicant:Zydus Pharms Usa Inc
Ingredient:losartan potassium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078243
Medical Subject Heading (MeSH) Categories for 078243
Suppliers and Packaging for NDA: 078243
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOSARTAN POTASSIUM losartan potassium TABLET;ORAL 078243 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7958 N 0615-7958-39
LOSARTAN POTASSIUM losartan potassium TABLET;ORAL 078243 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7959 N 0615-7959-05

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Dow
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Harvard Business School
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Fuji
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