Details for New Drug Application (NDA): 080475
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NDA 080475 describes METHYLTESTOSTERONE, which is a drug marketed by Heather, Impax Labs Inc, Novitium Pharma, Impax Labs, Lilly, Purepac Pharm, Pvt Form, Tablicaps, Usl Pharma, Inwood Labs, Kv Pharm, Lannett, Parke Davis, Watson Labs, and West Ward, and is included in twenty-eight NDAs. It is available from two suppliers. Additional details are available on the METHYLTESTOSTERONE profile page.
The generic ingredient in METHYLTESTOSTERONE 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 METHYLTESTOSTERONE 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 080475
| Tradename: | METHYLTESTOSTERONE |
| Applicant: | Purepac Pharm |
| Ingredient: | methyltestosterone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 080475
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;BUCCAL, SUBLINGUAL | 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;BUCCAL, SUBLINGUAL | Strength | 10MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;BUCCAL, SUBLINGUAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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