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Generated: November 14, 2018

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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 two 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-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 020297
Tradename:COREG
Applicant:Smithkline Beecham
Ingredient:carvedilol
Patents:0
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)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Expired US Patents for NDA 020297

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham COREG carvedilol TABLET;ORAL 020297-003 Sep 14, 1995 ➤ Sign Up ➤ Sign Up
Smithkline Beecham COREG carvedilol TABLET;ORAL 020297-004 May 29, 1997 ➤ Sign Up ➤ Sign Up
Smithkline Beecham COREG carvedilol TABLET;ORAL 020297-004 May 29, 1997 ➤ Sign Up ➤ Sign Up
Smithkline Beecham COREG carvedilol TABLET;ORAL 020297-001 Sep 14, 1995 ➤ Sign Up ➤ Sign Up
Smithkline Beecham COREG carvedilol TABLET;ORAL 020297-002 Sep 14, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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