Details for New Drug Application (NDA): 019834
✉ Email this page to a colleague
NDA 019834 describes PLENDIL, which is a drug marketed by Astrazeneca and is included in one NDA. Additional details are available on the PLENDIL profile page.
The generic ingredient in PLENDIL is felodipine. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.
The generic ingredient in PLENDIL is felodipine. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.
Summary for 019834
| Tradename: | PLENDIL |
| Applicant: | Astrazeneca |
| Ingredient: | felodipine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019834
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 25, 1991 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 25, 1991 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 22, 1994 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
