Details for New Drug Application (NDA): 020027
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NDA 020027 describes CARDIZEM, which is a drug marketed by Biovail, Biovail Labs Intl, and Bausch, and is included in six NDAs. It is available from five suppliers. Additional details are available on the CARDIZEM profile page.
The generic ingredient in CARDIZEM is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
The generic ingredient in CARDIZEM is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 020027
| Tradename: | CARDIZEM |
| Applicant: | Biovail Labs Intl |
| Ingredient: | diltiazem hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 24, 1991 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 18, 1995 | TE: | RLD: | Yes | |||||
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