Details for New Drug Application (NDA): 076846
✉ Email this page to a colleague
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 076846
Tradename: | AMLODIPINE BESYLATE |
Applicant: | Teva |
Ingredient: | amlodipine besylate |
Patents: | 0 |
Pharmacology for NDA: 076846
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Suppliers and Packaging for NDA: 076846
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 076846 | ANDA | Teva Pharmaceuticals, Inc. | 0480-0083 | 0480-0083-05 | 500 TABLET in 1 BOTTLE (0480-0083-05) |
AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 076846 | ANDA | Teva Pharmaceuticals, Inc. | 0480-0083 | 0480-0083-98 | 90 TABLET in 1 BOTTLE (0480-0083-98) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Jun 28, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Jun 28, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jun 28, 2007 | TE: | AB | RLD: | No |
Complete Access Available with Subscription