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Details for Generic Name: amlodipine besylate; telmisartan

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

There are fourty-six drug master file entries for amlodipine besylate; telmisartan. One supplier is listed for this compound.

Summary for Generic Name: amlodipine besylate; telmisartan

Drug Master File Entries: see list46
Suppliers: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: amlodipine besylate; telmisartan

Clinical Trials for: amlodipine besylate; telmisartan

Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
Status: Completed Condition: Hypertension

CKD-346 DDI Study(Telmisartan/S-Amlodipine, Rosuvastatin)
Status: Completed Condition: Hypertension; Hyperlipidemia

Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine
Status: Completed Condition: Essential Hypertension; Hyperlipidemia

Telmisartan, Amlodipine and Combination in Healthy Subjects
Status: Completed Condition: Healthy

The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine
Status: Completed Condition: Hypertension; Hyperlipidemia

CKD-828 (80/5mg) Pharmacokinetic Study
Status: Not yet recruiting Condition: Hypertension

A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients
Status: Completed Condition: Hypertension; Obesity

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
amlodipine besylate; telmisartan
TABLET;ORAL201586-003Jan 8, 2014RXNo<disabled><disabled>
Boehringer Ingelheim
amlodipine besylate; telmisartan
TABLET;ORAL022401-004Oct 16, 2009RXYes<disabled><disabled>
Lupin Ltd
amlodipine besylate; telmisartan
TABLET;ORAL201586-001Jan 8, 2014RXNo<disabled><disabled>
Mylan Pharms Inc
amlodipine besylate; telmisartan
TABLET;ORAL202516-001Aug 26, 2014RXNo<disabled><disabled>
Mylan Pharms Inc
amlodipine besylate; telmisartan
TABLET;ORAL202516-004Aug 26, 2014RXNo<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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