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Details for New Drug Application (NDA): 206302

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NDA 206302 describes BYVALSON, which is a drug marketed by Forest Labs Llc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the BYVALSON profile page.

The generic ingredient in BYVALSON is nebivolol hydrochloride; valsartan. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nebivolol hydrochloride; valsartan profile page.

Summary for NDA: 206302

Tradename:
BYVALSON
Applicant:
Forest Labs Llc
Ingredient:
nebivolol hydrochloride; valsartan
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 206302

Suppliers and Packaging for NDA: 206302

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BYVALSON
nebivolol hydrochloride; valsartan
TABLET;ORAL 206302 NDA Allergan, Inc 0023-5874 0023-5874-30 30 TABLET, FILM COATED in 1 BOTTLE (0023-5874-30)
BYVALSON
nebivolol hydrochloride; valsartan
TABLET;ORAL 206302 NDA Allergan, Inc 0023-5874 0023-5874-32 5 BOTTLE in 1 TRAY (0023-5874-32) > 30 TABLET, FILM COATED in 1 BOTTLE (0023-5874-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;80MG
Approval Date:Jun 3, 2016TE:RLD:No
Patent:7,803,838Patent Expiration:Aug 29, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:7,838,552Patent Expiration:Oct 4, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERTENSION
Regulatory Exclusivity Expiration:Jun 3, 2019
Regulatory Exclusivity Use:NEW COMBINATION


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