Details for New Drug Application (NDA): 018976
✉ Email this page to a colleague
NDA 018976 describes LEVATOL, which is a drug marketed by Endo Operations and is included in one NDA. Additional details are available on the LEVATOL profile page.
The generic ingredient in LEVATOL is penbutolol sulfate. There are two drug master file entries for this compound. Additional details are available on the penbutolol sulfate profile page.
The generic ingredient in LEVATOL is penbutolol sulfate. There are two drug master file entries for this compound. Additional details are available on the penbutolol sulfate profile page.
Summary for 018976
| Tradename: | LEVATOL |
| Applicant: | Endo Operations |
| Ingredient: | penbutolol sulfate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018976
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 30, 1987 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 5, 1989 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
