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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
US Army

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201586

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NDA 201586 describes TELMISARTAN AND AMLODIPINE, which is a drug marketed by Alembic Pharms Ltd, Lupin Ltd, Mylan Pharms Inc, and Torrent Pharms Ltd, and is included in four NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; telmisartan profile page.
Summary for 201586
Applicant:Lupin Ltd
Ingredient:amlodipine besylate; telmisartan
Formulation / Manufacturing:see details
Pharmacology for NDA: 201586
Suppliers and Packaging for NDA: 201586
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TELMISARTAN AND AMLODIPINE amlodipine besylate; telmisartan TABLET;ORAL 201586 ANDA AvKARE, Inc. 42291-793 N 42291-793-30
TELMISARTAN AND AMLODIPINE amlodipine besylate; telmisartan TABLET;ORAL 201586 ANDA AvKARE, Inc. 42291-794 N 42291-794-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;40MG
Approval Date:Jan 8, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;40MG
Approval Date:Jan 8, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;80MG
Approval Date:Jan 8, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Johnson and Johnson

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