Details for New Drug Application (NDA): 074582
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NDA 074582 describes DANAZOL, which is a drug marketed by Am Therap, Barr, and Lannett Co Inc, and is included in three NDAs. It is available from four suppliers. Additional details are available on the DANAZOL profile page.
The generic ingredient in DANAZOL is danazol. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the danazol profile page.
The generic ingredient in DANAZOL is danazol. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the danazol profile page.
Pharmacology for NDA: 074582
| Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 074582
Suppliers and Packaging for NDA: 074582
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DANAZOL | danazol | CAPSULE;ORAL | 074582 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0633 | 0555-0633-02 | 100 CAPSULE in 1 BOTTLE (0555-0633-02) |
| DANAZOL | danazol | CAPSULE;ORAL | 074582 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0634 | 0555-0634-02 | 100 CAPSULE in 1 BOTTLE (0555-0634-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 9, 1996 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | May 29, 1998 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | May 29, 1998 | TE: | AB | RLD: | No | ||||
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