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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 022012


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NDA 022012 describes COREG CR, which is a drug marketed by Woodward and is included in one NDA. It is available from four suppliers. There is one patent 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. Eight suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 022012
Tradename:COREG CR
Applicant:Woodward
Ingredient:carvedilol phosphate
Patents:1
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 0007-3383 0007-3383-13 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3383-13)
COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012 NDA GlaxoSmithKline LLC 0007-3385 0007-3385-13 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3385-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 20, 2006TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent 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:⤷  Try a TrialPatent Expiration:Mar 11, 2026Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Oct 20, 2006TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 11, 2026Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022012

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-004 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
Woodward COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.