Last Updated: May 10, 2026

Details for New Drug Application (NDA): 020297


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NDA 020297 describes COREG, which is a drug marketed by Waylis Therap and is included in two NDAs. It is available from one supplier. There is one patent 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. Nine suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 020297
Tradename:COREG
Applicant:Waylis Therap
Ingredient:carvedilol
Patents:0
Pharmacology for NDA: 020297
Mechanism of ActionAdrenergic alpha-Antagonists
Adrenergic beta1-Antagonists
Adrenergic beta2-Antagonists
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 Waylis Therapeutics LLC 80725-139 80725-139-20 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-139-20)
COREG carvedilol TABLET;ORAL 020297 NDA Waylis Therapeutics LLC 80725-140 80725-140-20 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-140-20)

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

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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