Details for New Drug Application (NDA): 018976
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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: | Auxilium Pharms Llc |
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| DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| DISCN | Dosage: | TABLET;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 |
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