Details for New Drug Application (NDA): 021956
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NDA 021956 describes DUTOPROL, which is a drug marketed by Concordia and is included in one NDA. Additional details are available on the DUTOPROL profile page.
The generic ingredient in DUTOPROL is hydrochlorothiazide; metoprolol succinate. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; metoprolol succinate profile page.
The generic ingredient in DUTOPROL is hydrochlorothiazide; metoprolol succinate. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; metoprolol succinate profile page.
Summary for 021956
| Tradename: | DUTOPROL |
| Applicant: | Concordia |
| Ingredient: | hydrochlorothiazide; metoprolol succinate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | 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RELEASE;ORAL | Strength | 12.5MG;EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 28, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | 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RELEASE;ORAL | Strength | 12.5MG;EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 28, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | 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| Strength | 12.5MG;EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 28, 2006 | TE: | RLD: | Yes | |||||
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