Details for New Drug Application (NDA): 022217
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The generic ingredient in VALTURNA is aliskiren hemifumarate; valsartan. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; valsartan profile page.
Summary for 022217
| Tradename: | VALTURNA |
| Applicant: | Novartis |
| Ingredient: | aliskiren hemifumarate; valsartan |
| Patents: | 1 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE;160MG | ||||
| Approval Date: | Sep 16, 2009 | TE: | RLD: | No | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 3, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE;320MG | ||||
| Approval Date: | Sep 16, 2009 | TE: | RLD: | No | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 3, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022217
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Start Trial | ⤷ Start Trial |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | ⤷ Start Trial | ⤷ Start Trial |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | ⤷ Start Trial | ⤷ Start Trial |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Start Trial | ⤷ Start Trial |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Start Trial | ⤷ Start Trial |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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