Details for New Drug Application (NDA): 017557
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NDA 017557 describes DANOCRINE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the DANOCRINE profile page.
The generic ingredient in DANOCRINE is danazol. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the danazol profile page.
The generic ingredient in DANOCRINE is danazol. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the danazol profile page.
Summary for 017557
| Tradename: | DANOCRINE |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | danazol |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017557
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | No | |||||
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