Details for New Drug Application (NDA): 003158
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NDA 003158 describes ORETON METHYL, which is a drug marketed by Schering and is included in one NDA. Additional details are available on the ORETON METHYL profile page.
The generic ingredient in ORETON METHYL is methyltestosterone. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methyltestosterone profile page.
The generic ingredient in ORETON METHYL is methyltestosterone. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methyltestosterone profile page.
Summary for 003158
| Tradename: | ORETON METHYL |
| Applicant: | Schering |
| Ingredient: | methyltestosterone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 003158
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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