Details for New Drug Application (NDA): 021742

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NDA 021742 describes BYSTOLIC, which is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. 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. Twenty-three suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.

Summary for 021742

Tradename:	BYSTOLIC
Applicant:	Allergan
Ingredient:	nebivolol hydrochloride
Patents:	0

Pharmacology for NDA: 021742

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 021742

Adrenergic beta-1 Receptor Agonists
Antihypertensive Agents
Vasodilator Agents

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, Inc.	0456-1402	0456-1402-01	100 TABLET in 1 BOTTLE (0456-1402-01)
BYSTOLIC	nebivolol hydrochloride	TABLET;ORAL	021742	NDA	Allergan, Inc.	0456-1402	0456-1402-30	30 TABLET in 1 BOTTLE (0456-1402-30)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Dec 17, 2007	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Dec 17, 2007	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Dec 17, 2007	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021742

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

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