Details for New Drug Application (NDA): 206302
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NDA 206302 describes BYVALSON, which is a drug marketed by Abbvie and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BYVALSON profile page.
The generic ingredient in BYVALSON is nebivolol hydrochloride; valsartan. There are fourteen drug master file entries for this compound. Additional details are available on the nebivolol hydrochloride; valsartan profile page.
The generic ingredient in BYVALSON is nebivolol hydrochloride; valsartan. There are fourteen drug master file entries for this compound. Additional details are available on the nebivolol hydrochloride; valsartan profile page.
Summary for 206302
| Tradename: | BYVALSON |
| Applicant: | Abbvie |
| Ingredient: | nebivolol hydrochloride; valsartan |
| Patents: | 2 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;80MG | ||||
| Approval Date: | Jun 3, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 7,803,838 | Patent Expiration: | Aug 29, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,838,552 | Patent Expiration: | Oct 4, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING HYPERTENSION | ||||||||
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