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Details for New Drug Application (NDA): 202829
The generic ingredient in AMLODIPINE BESYLATE AND VALSARTAN is amlodipine besylate; valsartan. There are fifty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.
Summary for 202829
Tradename: | AMLODIPINE BESYLATE AND VALSARTAN |
Applicant: | Novel Labs Inc |
Ingredient: | amlodipine besylate; valsartan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202829
Ingredient-type | Dihydropyridines |
Mechanism of Action | Calcium Channel Antagonists Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 202829
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 202829 | ANDA | Novel Laboratories, Inc. | 40032-080 | E | 40032-080-03 |
AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 202829 | ANDA | Novel Laboratories, Inc. | 40032-080 | E | 40032-080-09 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;160MG | ||||
Approval Date: | Mar 30, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;160MG | ||||
Approval Date: | Mar 30, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;320MG | ||||
Approval Date: | Mar 30, 2015 | TE: | AB | RLD: | No |
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