Details for New Drug Application (NDA): 016885
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NDA 016885 describes LYSODREN, which is a drug marketed by Hra Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the LYSODREN profile page.
The generic ingredient in LYSODREN is mitotane. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mitotane profile page.
The generic ingredient in LYSODREN is mitotane. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mitotane profile page.
Summary for 016885
| Tradename: | LYSODREN |
| Applicant: | Hra Pharma |
| Ingredient: | mitotane |
| Patents: | 0 |
Pharmacology for NDA: 016885
| Mechanism of Action | Cytochrome P450 3A4 Inducers |
Medical Subject Heading (MeSH) Categories for 016885
Suppliers and Packaging for NDA: 016885
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYSODREN | mitotane | TABLET;ORAL | 016885 | NDA | HRA Pharma Rare Diseases | 76336-080 | 76336-080-60 | 1 BOTTLE in 1 CARTON (76336-080-60) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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