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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Federal Trade Commission
Daiichi Sankyo
Farmers Insurance
Harvard Business School
Julphar
Moodys
Cipla
Chubb
McKinsey

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203010

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NDA 203010 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 203010

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203010

Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 203010

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010 ANDA Alembic Pharmaceuticals Limited 46708-209 46708-209-30 30 TABLET in 1 BOTTLE (46708-209-30)
TELMISARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; telmisartan TABLET;ORAL 203010 ANDA Alembic Pharmaceuticals Limited 46708-209 46708-209-10 100 TABLET in 1 CARTON (46708-209-10)

Summary for product number 001

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

Summary for product number 002

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

Summary 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:

Julphar
Medtronic
Merck
Novartis
McKesson
US Army
Chinese Patent Office
Fuji
UBS
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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