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Generated: July 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020297

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NDA 020297 describes COREG, which is a drug marketed by Smithkline Beecham and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the COREG profile page.

The generic ingredient in COREG is carvedilol phosphate. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.

Summary for NDA: 020297

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020297

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COREG
carvedilol
TABLET;ORAL 020297 NDA GlaxoSmithKline LLC 0007-4139 0007-4139-20 100 TABLET, FILM COATED in 1 BOTTLE (0007-4139-20)
COREG
carvedilol
TABLET;ORAL 020297 NDA GlaxoSmithKline LLC 0007-4140 0007-4140-20 100 TABLET, FILM COATED in 1 BOTTLE (0007-4140-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 14, 1995TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Sep 14, 1995TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength6.25MG
Approval Date:Sep 14, 1995TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020297

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham
COREG
carvedilol
TABLET;ORAL020297-003Sep 14, 1995► Subscribe► Subscribe
Smithkline Beecham
COREG
carvedilol
TABLET;ORAL020297-001Sep 14, 1995► Subscribe► Subscribe
Smithkline Beecham
COREG
carvedilol
TABLET;ORAL020297-002Sep 14, 1995► Subscribe► Subscribe
Smithkline Beecham
COREG
carvedilol
TABLET;ORAL020297-004May 29, 1997► Subscribe► Subscribe
Smithkline Beecham
COREG
carvedilol
TABLET;ORAL020297-001Sep 14, 1995► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Colorcon
Cipla
Fish and Richardson
Johnson and Johnson
Dow
Moodys
Cerilliant
Covington
UBS
Queensland Health

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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