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Generated: December 16, 2018

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Details for New Drug Application (NDA): 022012

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NDA 022012 describes COREG CR, which is a drug marketed by Smithkline Beecham and is included in one NDA. 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 CR profile page.

The generic ingredient in COREG CR 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 022012
Tradename:COREG CR
Applicant:Smithkline Beecham
Ingredient:carvedilol phosphate
Patents:2
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022012
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012 NDA GlaxoSmithKline LLC 0007-3370 0007-3370-13 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3370-13)
COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012 NDA GlaxoSmithKline LLC 0007-3371 0007-3371-13 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3371-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 20, 2006TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 27, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Mar 11, 2026Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Oct 20, 2006TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 27, 2023Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022012

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006 ➤ Sign Up ➤ Sign Up
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-004 Oct 20, 2006 ➤ Sign Up ➤ Sign Up
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006 ➤ Sign Up ➤ Sign Up
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-004 Oct 20, 2006 ➤ Sign Up ➤ Sign Up
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-004 Oct 20, 2006 ➤ Sign Up ➤ Sign Up
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006 ➤ Sign Up ➤ Sign Up
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-001 Oct 20, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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