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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 202130


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NDA 202130 describes TELMISARTAN, which is a drug marketed by Alembic, Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Mankind Pharma, Micro Labs, Mylan, Prinston Inc, Sandoz, Torrent, Zydus Pharms, Lupin Ltd, Macleods Pharms Ltd, and Natco, and is included in thirty NDAs. It is available from twenty-six 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. Ten suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 202130
Tradename:TELMISARTAN
Applicant:Alembic
Ingredient:telmisartan
Patents:0
Pharmacology for NDA: 202130
Suppliers and Packaging for NDA: 202130
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN telmisartan TABLET;ORAL 202130 ANDA medsource pharmaceuticals 45865-836 45865-836-60 60 TABLET in 1 BOTTLE (45865-836-60)
TELMISARTAN telmisartan TABLET;ORAL 202130 ANDA Alembic Pharmaceuticals Limited 46708-608 46708-608-10 100 TABLET in 1 CARTON (46708-608-10)

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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