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Generated: September 23, 2017

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Details for New Drug Application (NDA): 203867

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NDA 203867 describes TELMISARTAN, which is a drug marketed by Hetero Labs Ltd V, Cadila Pharms Ltd, Watson Labs, Aurobindo Pharma Ltd, Amneal Pharms, Zydus Pharms Usa Inc, Alembic Pharms Ltd, Glenmark Pharms Ltd, Inventia Hlthcare, Jubilant Generics, Sandoz Inc, Torrent Pharms Ltd, Prinston Inc, Mylan Pharms Inc, Lupin Ltd, and Macleods Pharms Ltd, and is included in twenty-five NDAs. It is available from seventeen suppliers. Additional details are available on the TELMISARTAN profile page.

The generic ingredient in TELMISARTAN 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 NDA: 203867

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

Pharmacology for NDA: 203867

Mechanism of Action	Angiotensin 2 Receptor Antagonists

Suppliers and Packaging for NDA: 203867

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TELMISARTAN	telmisartan	TABLET;ORAL	203867	ANDA	Sandoz Inc	0781-5372	0781-5372-06	10 TABLET in 1 BLISTER PACK (0781-5372-06)
TELMISARTAN	telmisartan	TABLET;ORAL	203867	ANDA	Sandoz Inc	0781-5372	0781-5372-64	30 TABLET in 1 CARTON (0781-5372-64)

Summary for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Nov 3, 2014	TE:	AB	RLD:	No

Summary for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Nov 3, 2014	TE:	AB	RLD:	No

Summary for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Nov 3, 2014	TE:	AB	RLD:	No

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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.