Details for New Drug Application (NDA): 009519
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NDA 009519 describes DORIDEN, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the DORIDEN profile page.
The generic ingredient in DORIDEN is glutethimide. There are four drug master file entries for this compound. Additional details are available on the glutethimide profile page.
The generic ingredient in DORIDEN is glutethimide. There are four drug master file entries for this compound. Additional details are available on the glutethimide profile page.
Summary for 009519
| Tradename: | DORIDEN |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | glutethimide |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 009519
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 008
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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