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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021742

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NDA 021742 describes BYSTOLIC, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the BYSTOLIC profile page.

The generic ingredient in BYSTOLIC is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
Summary for 021742
Tradename:BYSTOLIC
Applicant:Allergan Sales Llc
Ingredient:nebivolol hydrochloride
Patents:1
Pharmacology for NDA: 021742
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 021742
Suppliers and Packaging for NDA: 021742
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742 NDA Allergan USA, Inc. 0456-1402 0456-1402-01 100 TABLET in 1 BOTTLE (0456-1402-01)
BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742 NDA Allergan USA, Inc. 0456-1402 0456-1402-30 30 TABLET in 1 BOTTLE (0456-1402-30)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Dec 17, 2007TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 17, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Dec 17, 2007TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 17, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Dec 17, 2007TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 17, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION

Expired US Patents for NDA 021742

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-002 Dec 17, 2007 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-005 Oct 8, 2008 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-004 Dec 17, 2007 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc BYSTOLIC nebivolol hydrochloride TABLET;ORAL 021742-003 Dec 17, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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