Details for New Drug Application (NDA): 078021
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The generic ingredient in AMLODIPINE BESYLATE 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 078021
Tradename: | AMLODIPINE BESYLATE |
Applicant: | Aurobindo Pharma |
Ingredient: | amlodipine besylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078021
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Suppliers and Packaging for NDA: 078021
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 078021 | ANDA | Aurobindo Pharma Limited | 65862-101 | 65862-101-05 | 500 TABLET in 1 BOTTLE (65862-101-05) |
AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 078021 | ANDA | Aurobindo Pharma Limited | 65862-101 | 65862-101-30 | 30 TABLET in 1 BOTTLE (65862-101-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Jul 17, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Jul 17, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jul 17, 2007 | TE: | AB | RLD: | No |
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