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Summary for Tradename: EXFORGE
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Clinical Trials for: EXFORGEPhase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg Status: Completed Condition: Healthy Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet Status: Completed Condition: Healthy A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers Status: Completed Condition: Healthy Male Volunteer Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301) Status: Completed Condition: Hypertension Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients Status: Completed Condition: Hypertension Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60) Status: Recruiting Condition: Healthy Male Subjects Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension. Status: Completed Condition: Hypertension Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension Status: Completed Condition: Hypertension A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy Status: Completed Condition: Primary Hypertension One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension Status: Completed Condition: Hypertension Courtesy of ClinicalTrials.org See more clinical trials for this drug | ||||||||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Product | Substance | Delist_Flag | Patent Expiration | Exclusivity Expiration | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET; ORAL | 021990 | Jun 20, 2007 | RX | No | 5,399,578*PED | <disabled> | <disabled> | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET; ORAL | 021990 | Jun 20, 2007 | RX | No | 6,294,197*PED | Y | <disabled> | <disabled> | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET; ORAL | 021990 | Jun 20, 2007 | RX | No | 6,395,728 | Y | <disabled> | <disabled> | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET; ORAL | 021990 | Jun 20, 2007 | RX | Yes | 5,399,578*PED | <disabled> | <disabled> | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
| amlodipine, hydrochlorothiazide and valsartan | Tablets | 10 mg/12.5 mg/160 mg | Exforge HCT | 10/22/2009 |
| amlodipine, hydrochlorothiazide and valsartan | Tablets | 5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 m | Exforge HCT | 9/14/2009 |
| amlodipine besylate and valsartan | Tablets | 5 mg/320 mg | Exforge | 11/26/2007 |
| amlodipine besylate and valsartan | Tablets | 10 mg/320 mg | Exforge | 11/9/2007 |
| amlodipine besylate and valsartan | Tablets | 5 mg/160 mg | Exforge | 10/22/2007 |
| amlodipine besylate and valsartan | Tablets | 10 mg/160 mg | Exforge | 10/1/2007 |
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