Details for New Drug Application (NDA): 205137
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NDA 205137 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 205137
| Tradename: | AMLODIPINE BESYLATE AND VALSARTAN |
| Applicant: | Hetero Labs |
| Ingredient: | amlodipine besylate; valsartan |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;160MG | ||||
| Approval Date: | Sep 16, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;160MG | ||||
| Approval Date: | Sep 16, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;320MG | ||||
| Approval Date: | Sep 16, 2016 | TE: | AB | RLD: | No | ||||
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