Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021956

Expand all

DUTOPROL (HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE)
12.5MG;EQ 25MG TARTRATE
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
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
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
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
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English