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Colorcon
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Farmers Insurance
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Moodys
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Mallinckrodt

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205901

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NDA 205901 describes TELMISARTAN, which is a drug marketed by Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd V, Inventia Hlthcare, Jubilant Generics, Micro Labs, Mylan Pharms Inc, Prinston Inc, Sandoz Inc, Torrent Pharms Ltd, Watson Labs, Zydus Pharms Usa Inc, Lupin Ltd, and Macleods Pharms Ltd, and is included in twenty-seven NDAs. It is available from twenty suppliers. Additional details are available on the TELMISARTAN profile page.

The generic ingredient in TELMISARTAN is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 205901
Tradename:TELMISARTAN
Applicant:Hetero Labs Ltd V
Ingredient:telmisartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205901
Suppliers and Packaging for NDA: 205901
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN telmisartan TABLET;ORAL 205901 ANDA Camber Pharmaceuticals, Inc. 31722-802 N 31722-802-33
TELMISARTAN telmisartan TABLET;ORAL 205901 ANDA Camber Pharmaceuticals, Inc. 31722-802 N 31722-802-36

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 22, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Apr 22, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Apr 22, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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