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Details for New Drug Application (NDA): 202829
NDA 202829 describes AMLODIPINE BESYLATE AND VALSARTAN, which is a drug marketed by Alembic Pharms Ltd, Aurobindo Pharma Ltd, Invagen Pharms, Lupin, Mylan Pharms Inc, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the AMLODIPINE BESYLATE AND VALSARTAN profile page.
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.
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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