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Last Updated: February 24, 2021

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Details for New Drug Application (NDA): 203171

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NDA 203171 describes TELMISARTAN, which is a drug marketed by Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Celltrion, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Micro Labs, Mylan, Prinston Inc, Sandoz Inc, Torrent, Zydus Pharms, Lupin Ltd, and Macleods Pharms Ltd, and is included in twenty-nine NDAs. It is available from twenty-one 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 203171
Tradename:TELMISARTAN
Applicant:Torrent
Ingredient:telmisartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203171
Suppliers and Packaging for NDA: 203171
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN telmisartan TABLET;ORAL 203171 ANDA Torrent Pharmaceuticals Limited 13668-156 13668-156-01 100 TABLET in 1 BOTTLE (13668-156-01)
TELMISARTAN telmisartan TABLET;ORAL 203171 ANDA Torrent Pharmaceuticals Limited 13668-156 13668-156-30 30 TABLET in 1 BOTTLE (13668-156-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jul 7, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jul 7, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jul 7, 2014TE:ABRLD:No

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