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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078710

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NDA 078710 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 eighteen 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 078710

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

Pharmacology for NDA: 078710

Suppliers and Packaging for NDA: 078710

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN telmisartan TABLET;ORAL 078710 ANDA Actavis Pharma, Inc. 0591-3292 0591-3292-15 3 BLISTER PACK in 1 CARTON (0591-3292-15) > 10 TABLET in 1 BLISTER PACK
TELMISARTAN telmisartan TABLET;ORAL 078710 ANDA Actavis Pharma, Inc. 0591-3293 0591-3293-15 3 BLISTER PACK in 1 CARTON (0591-3293-15) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jan 8, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jan 8, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jan 8, 2014TE:ABRLD:No


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