Details for New Drug Application (NDA): 016979
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NDA 016979 describes MEGACE, which is a drug marketed by Bristol Myers Squibb and Endo Operations and is included in three NDAs. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MEGACE profile page.
The generic ingredient in MEGACE is megestrol acetate. There are eighteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
The generic ingredient in MEGACE is megestrol acetate. There are eighteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.
Summary for 016979
| Tradename: | MEGACE |
| Applicant: | Bristol Myers Squibb |
| Ingredient: | megestrol acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 016979
Profile for product number 001
| 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| DISCN | Dosage: | TABLET;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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