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Last Updated: March 19, 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 Action	Adrenergic 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:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Sep 14, 1995	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Sep 14, 1995	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	6.25MG
Approval Date:	Sep 14, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020297

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	RE40000*PED	⤷ Get Started Free
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-004	May 29, 1997	4,503,067*PED	⤷ Get Started Free
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995	RE40000*PED	⤷ Get Started Free
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-003	Sep 14, 1995	4,503,067*PED	⤷ Get Started Free
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995	5,902,821*PED	⤷ Get Started Free
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-001	Sep 14, 1995	5,760,069*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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