Details for New Drug Application (NDA): 078477
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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 078477
Tradename: | AMLODIPINE BESYLATE |
Applicant: | Amneal Pharms Ny |
Ingredient: | amlodipine besylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078477
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Suppliers and Packaging for NDA: 078477
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 078477 | ANDA | Amneal Pharmaceuticals LLC | 65162-006 | 65162-006-03 | 30 TABLET in 1 BOTTLE (65162-006-03) |
AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 078477 | ANDA | Amneal Pharmaceuticals LLC | 65162-006 | 65162-006-09 | 90 TABLET in 1 BOTTLE (65162-006-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Jan 16, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Jan 16, 2008 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jan 16, 2008 | TE: | RLD: | No |
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