Details for New Drug Application (NDA): 202829
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NDA 202829 describes AMLODIPINE BESYLATE AND VALSARTAN, which is a drug marketed by Alembic, Aurobindo Pharma, Hetero Labs, Lupin, Mylan, Novel Labs Inc, Strides Pharma, Teva Pharms Usa, and Torrent, and is included in nine NDAs. It is available from eight 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. Nine 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. Nine 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 |
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 | Lupin Pharmaceuticals,Inc. | 43386-080 | 43386-080-03 | 30 TABLET in 1 BOTTLE (43386-080-03) |
| AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 202829 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-080 | 43386-080-09 | 90 TABLET in 1 BOTTLE (43386-080-09) |
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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