Details for New Drug Application (NDA): 019471
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The generic ingredient in CARDIZEM SR is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 019471
Tradename: | CARDIZEM SR |
Applicant: | Biovail |
Ingredient: | diltiazem hydrochloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jan 23, 1989 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jan 23, 1989 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jan 23, 1989 | TE: | RLD: | Yes |
Expired US Patents for NDA 019471
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Biovail | CARDIZEM SR | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019471-004 | Jan 23, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Biovail | CARDIZEM SR | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019471-001 | Jan 23, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Biovail | CARDIZEM SR | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019471-003 | Jan 23, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Biovail | CARDIZEM SR | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019471-002 | Jan 23, 1989 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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