Details for New Drug Application (NDA): 206180
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The generic ingredient in AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 206180
Tradename: | AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | amlodipine besylate; hydrochlorothiazide; valsartan |
Patents: | 0 |
Pharmacology for NDA: 206180
Mechanism of Action | Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 206180
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 206180 | ANDA | Aurobindo Pharma Limited | 65862-834 | 65862-834-05 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-834-05) |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 206180 | ANDA | Aurobindo Pharma Limited | 65862-834 | 65862-834-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-834-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;12.5MG;160MG | ||||
Approval Date: | Dec 19, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;25MG;160MG | ||||
Approval Date: | Dec 19, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;12.5MG;160MG | ||||
Approval Date: | Dec 19, 2017 | TE: | AB | RLD: | No |
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