Details for New Drug Application (NDA): 020005
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The generic ingredient in CARDENE SR is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 020005
Tradename: | CARDENE SR |
Applicant: | Chiesi |
Ingredient: | nicardipine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 020005
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 21, 1992 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 21, 1992 | TE: | RLD: | Yes |
Profile for product number 003
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CAPSULE, EXTENDED RELEASE;ORAL | Strength | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | Feb 21, 1992 | TE: | RLD: | Yes |
Expired US Patents for NDA 020005
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