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Amlodipine besylate; telmisartan - Generic Drug Details

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Amlodipine besylate; telmisartan is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Mylan Pharms Inc, Torrent Pharms Ltd, and Lupin Ltd, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-eight drug master file entries for amlodipine besylate; telmisartan. Four suppliers are listed for this compound.

Summary for Generic Name: amlodipine besylate; telmisartan

Tradenames:2
Patents:0
Applicants:4
NDAs:4
Drug Master File Entries: see list48
Suppliers / Packaging: see list4
Formulation / Manufacturing:see details

Pharmacology for Ingredient: amlodipine besylate; telmisartan

Clinical Trials for: amlodipine besylate; telmisartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
TELMISARTAN AND AMLODIPINE
amlodipine besylate; telmisartan
TABLET;ORAL201586-003Jan 8, 2014RXNo<disabled><disabled>
Mylan Pharms Inc
TELMISARTAN AND AMLODIPINE
amlodipine besylate; telmisartan
TABLET;ORAL202516-003Aug 26, 2014RXNo<disabled><disabled>
Boehringer Ingelheim
TWYNSTA
amlodipine besylate; telmisartan
TABLET;ORAL022401-001Oct 16, 2009RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; telmisartan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
TWYNSTA
amlodipine besylate; telmisartan
TABLET;ORAL022401-001Oct 16, 20095,591,762<disabled>
Boehringer Ingelheim
TWYNSTA
amlodipine besylate; telmisartan
TABLET;ORAL022401-003Oct 16, 20095,591,762<disabled>
Boehringer Ingelheim
TWYNSTA
amlodipine besylate; telmisartan
TABLET;ORAL022401-002Oct 16, 20095,591,762<disabled>
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