Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022012

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COREG CR (CARVEDILOL PHOSPHATE)
10MG Marketing Status: Prescription

Active Ingredient: CARVEDILOL PHOSPHATE
Proprietary Name: COREG CR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022012
Product Number: 001
Approval Date: Oct 20, 2006
Applicant Holder Full Name: SMITHKLINE BEECHAM (CORK) LTD IRELAND
Marketing Status:  Prescription
Patent and Exclusivity Information

COREG CR (CARVEDILOL PHOSPHATE)
20MG Marketing Status: Prescription

Active Ingredient: CARVEDILOL PHOSPHATE
Proprietary Name: COREG CR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022012
Product Number: 002
Approval Date: Oct 20, 2006
Applicant Holder Full Name: SMITHKLINE BEECHAM (CORK) LTD IRELAND
Marketing Status:  Prescription
Patent and Exclusivity Information

COREG CR (CARVEDILOL PHOSPHATE)
40MG Marketing Status: Prescription

Active Ingredient: CARVEDILOL PHOSPHATE
Proprietary Name: COREG CR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022012
Product Number: 003
Approval Date: Oct 20, 2006
Applicant Holder Full Name: SMITHKLINE BEECHAM (CORK) LTD IRELAND
Marketing Status:  Prescription
Patent and Exclusivity Information

COREG CR (CARVEDILOL PHOSPHATE)
80MG Marketing Status: Prescription

Active Ingredient: CARVEDILOL PHOSPHATE
Proprietary Name: COREG CR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022012
Product Number: 004
Approval Date: Oct 20, 2006
Applicant Holder Full Name: SMITHKLINE BEECHAM (CORK) LTD IRELAND
Marketing Status:  Prescription
Patent and Exclusivity Information

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