Details for New Drug Application (NDA): 090483
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NDA 090483 describes AMLODIPINE BESYLATE AND VALSARTAN, which is a drug marketed by Alembic, Aurobindo Pharma, Hetero Labs, Lupin, Macleods Pharms Ltd, Mylan, Novel Labs Inc, Strides Pharma Intl, Teva Pharms Usa, and Torrent, and is included in ten NDAs. It is available from nine 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.
Summary for 090483
| Tradename: | AMLODIPINE BESYLATE AND VALSARTAN |
| Applicant: | Mylan |
| Ingredient: | amlodipine besylate; valsartan |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090483
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090483 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1721 | 0378-1721-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1721-93) |
| AMLODIPINE BESYLATE AND VALSARTAN | amlodipine besylate; valsartan | TABLET;ORAL | 090483 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1722 | 0378-1722-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1722-93) |
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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