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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021956

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DUTOPROL (HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE)
12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
Proprietary Name: DUTOPROL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021956
Product Number: 001
Approval Date: Aug 28, 2006
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DUTOPROL (HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE)
12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
Proprietary Name: DUTOPROL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021956
Product Number: 002
Approval Date: Aug 28, 2006
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DUTOPROL (HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE)
12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
Proprietary Name: DUTOPROL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021956
Product Number: 003
Approval Date: Aug 28, 2006
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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