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Details for New Drug Application (NDA): 021742

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NDA 021742 describes BYSTOLIC, which is a drug marketed by Forest Labs and is included in one NDA. It is available from six 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 thirteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.

Summary for NDA: 021742

Tradename:
BYSTOLIC
Applicant:
Forest Labs
Ingredient:
nebivolol hydrochloride
Patents:1

Pharmacology for NDA: 021742

Mechanism of ActionAdrenergic beta-Antagonists

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Dec 17, 2007TE:RLD:No
Patent:6,545,040Patent Expiration:Dec 17, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Dec 17, 2007TE:RLD:No
Patent:6,545,040Patent Expiration:Dec 17, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Dec 17, 2007TE:RLD:No
Patent:6,545,040Patent Expiration:Dec 17, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION

Expired Orange Book Patents for NDA: 021742

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-002Dec 17, 20075,759,580► subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-005Oct 8, 20085,759,580► subscribe
Forest Labs
BYSTOLIC
nebivolol hydrochloride
TABLET;ORAL021742-004Dec 17, 20075,759,580► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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