Details for New Drug Application (NDA): 017388
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NDA 017388 describes GYNOREST, which is a drug marketed by Solvay and is included in one NDA. Additional details are available on the GYNOREST profile page.
The generic ingredient in GYNOREST is dydrogesterone. There is one drug master file entry for this compound. Additional details are available on the dydrogesterone profile page.
The generic ingredient in GYNOREST is dydrogesterone. There is one drug master file entry for this compound. Additional details are available on the dydrogesterone profile page.
Summary for 017388
| Tradename: | GYNOREST |
| Applicant: | Solvay |
| Ingredient: | dydrogesterone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017388
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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