Last Updated: November 9, 2026

Details for New Drug Application (NDA): 205234

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NDA 205234 describes TELMISARTAN AND AMLODIPINE, which is a drug marketed by Alembic, Lupin, Mylan, and Torrent, and is included in four NDAs. It is available from three suppliers. Additional details are available on the TELMISARTAN AND AMLODIPINE profile page.

The generic ingredient in TELMISARTAN AND AMLODIPINE is amlodipine besylate; telmisartan. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the amlodipine besylate; telmisartan profile page.
Summary for 205234
Tradename:TELMISARTAN AND AMLODIPINE
Applicant:Alembic
Ingredient:amlodipine besylate; telmisartan
Patents:0
Pharmacology for NDA: 205234
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Calcium Channel Antagonists
Cytochrome P450 3A Inhibitors
Suppliers and Packaging for NDA: 205234
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN AND AMLODIPINE amlodipine besylate; telmisartan TABLET;ORAL 205234 ANDA Alembic Pharmaceuticals Limited 46708-184 46708-184-10 30 BLISTER PACK in 1 CARTON (46708-184-10) / 10 TABLET in 1 BLISTER PACK (46708-184-03)
TELMISARTAN AND AMLODIPINE amlodipine besylate; telmisartan TABLET;ORAL 205234 ANDA Alembic Pharmaceuticals Limited 46708-184 46708-184-30 30 TABLET in 1 BOTTLE (46708-184-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE;40MG
Approval Date:Nov 17, 2016TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE;40MG
Approval Date:Nov 17, 2016TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE;80MG
Approval Date:Nov 17, 2016TE:RLD:No

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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