Details for New Drug Application (NDA): 022012

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NDA 022012 describes COREG CR, which is a drug marketed by Waylis Therap 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. Ten suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.

Summary for 022012

Tradename:	COREG CR
Applicant:	Waylis Therap
Ingredient:	carvedilol phosphate
Patents:	1

Pharmacology for NDA: 022012

Mechanism of Action	Adrenergic alpha-Antagonists Adrenergic beta1-Antagonists Adrenergic beta2-Antagonists

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	0007-3385	0007-3385-13	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3385-13)
COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012	NDA	GlaxoSmithKline LLC	0007-3387	0007-3387-13	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3387-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Oct 20, 2006	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 11, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	Oct 20, 2006	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 11, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	40MG
Approval Date:	Oct 20, 2006	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 11, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022012

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
Waylis Therap	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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