Details for New Drug Application (NDA): 080767
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NDA 080767 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 080767
| Tradename: | METHYLTESTOSTERONE |
| Applicant: | Impax Labs |
| Ingredient: | methyltestosterone |
| Patents: | 0 |
Pharmacology for NDA: 080767
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 080767
Suppliers and Packaging for NDA: 080767
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLTESTOSTERONE | methyltestosterone | TABLET;ORAL | 080767 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-7037 | 0115-7037-01 | 100 TABLET in 1 BOTTLE (0115-7037-01) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | BP | RLD: | No | ||||
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