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Serving leading biopharmaceutical companies globally:

McKesson
Covington
Merck
Dow
Citi
Express Scripts
McKinsey
Julphar
Fuji
Boehringer Ingelheim

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201192

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NDA 201192 describes TELMISARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the TELMISARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in TELMISARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; telmisartan. There are thirty-one 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 201192
Tradename:TELMISARTAN AND HYDROCHLOROTHIAZIDE
Applicant:Torrent Pharms Ltd
Ingredient:hydrochlorothiazide; telmisartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201192
Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 201192
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 201192 ANDA TORRENT PHARMACEUTICALS LIMITED 13668-159 13668-159-01 100 TABLET in 1 BOTTLE (13668-159-01)
TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 201192 ANDA TORRENT PHARMACEUTICALS LIMITED 13668-159 13668-159-72 30 TABLET in 1 CARTON (13668-159-72)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;40MG
Approval Date:Feb 25, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Feb 25, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;80MG
Approval Date:Feb 25, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Fish and Richardson
Deloitte
McKesson
Medtronic
Accenture
Johnson and Johnson
Colorcon
Baxter

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