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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202516


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NDA 202516 describes TELMISARTAN AND AMLODIPINE, which is a drug marketed by Alembic, Lupin Ltd, Mylan, and Torrent, and is included in four NDAs. It is available from two suppliers. Additional details are available on the TELMISARTAN AND AMLODIPINE profile page.

The generic ingredient in TELMISARTAN AND AMLODIPINE is amlodipine besylate; telmisartan. There are fifty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amlodipine besylate; telmisartan profile page.
Summary for 202516
Tradename:TELMISARTAN AND AMLODIPINE
Applicant:Mylan
Ingredient:amlodipine besylate; telmisartan
Patents:0
Pharmacology for NDA: 202516
Suppliers and Packaging for NDA: 202516
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN AND AMLODIPINE amlodipine besylate; telmisartan TABLET;ORAL 202516 ANDA Mylan Pharmaceuticals Inc. 0378-1075 0378-1075-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-1075-93)
TELMISARTAN AND AMLODIPINE amlodipine besylate; telmisartan TABLET;ORAL 202516 ANDA Mylan Pharmaceuticals Inc. 0378-1076 0378-1076-93 30 TABLET in 1 BOTTLE, PLASTIC (0378-1076-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;40MG
Approval Date:Aug 26, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;40MG
Approval Date:Aug 26, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;80MG
Approval Date:Aug 26, 2014TE:ABRLD:No

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