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Details for Generic Name: amlodipine besylate

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Summary for Generic Name: amlodipine besylate

Drug Master File Entries: see list46
Suppliers: see list12

Pharmacology for Ingredient: amlodipine besylate

Tentative approvals for AMLODIPINE BESYLATE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE; ORAL5MG; 20MG
<disabled><disabled>CAPSULE; ORAL10MG; 20MG
<disabled><disabled>CAPSULE; ORAL2.5MG; 10MG

Clinical Trials for: amlodipine besylate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
amlodipine besylate; atorvastatin calcium
TABLET; ORAL021540Jul 29, 2004RXNo6,455,574<disabled><disabled>
amlodipine besylate; valsartan
TABLET; ORAL021990Jun 20, 2007RXYes5,399,578*PED<disabled><disabled>
amlodipine besylate; valsartan
TABLET; ORAL021990Jun 20, 2007RXNo6,395,728<disabled>Y<disabled>
Kali Labs Inc
amlodipine besylate
TABLET; ORAL077516Jul 11, 2007RXNo<disabled><disabled>
Actavis Totowa
amlodipine besylate
TABLET; ORAL078131Sep 4, 2007RXNo<disabled><disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

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

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