Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020297

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COREG (CARVEDILOL)
3.125MG
Marketing Status: Prescription

Active Ingredient: CARVEDILOL
Proprietary Name: COREG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3.125MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020297
Product Number: 004
Approval Date: May 29, 1997
Applicant Holder Full Name: WAYLIS THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

COREG (CARVEDILOL)
6.25MG
Marketing Status: Prescription

Active Ingredient: CARVEDILOL
Proprietary Name: COREG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020297
Product Number: 003
Approval Date: Sep 14, 1995
Applicant Holder Full Name: WAYLIS THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

COREG (CARVEDILOL)
12.5MG
Marketing Status: Prescription

Active Ingredient: CARVEDILOL
Proprietary Name: COREG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020297
Product Number: 002
Approval Date: Sep 14, 1995
Applicant Holder Full Name: WAYLIS THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

COREG (CARVEDILOL)
25MG
Marketing Status: Prescription

Active Ingredient: CARVEDILOL
Proprietary Name: COREG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020297
Product Number: 001
Approval Date: Sep 14, 1995
Applicant Holder Full Name: WAYLIS THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information