Application 077246
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DANAZOL | DANAZOL | CAPSULE;ORAL | 200MG | No | No |
| 002 | DANAZOL | DANAZOL | CAPSULE;ORAL | 50MG | No | No |
| 003 | DANAZOL | DANAZOL | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-1369 | Danazol | Danazol | Lannett Company, Inc. | ANDA | Current |
| 0527-1369 | Danazol | Danazol | Lannett Company, Inc. | ANDA | Current |
| 0527-1369 | Danazol | Danazol | Lannett Company, Inc. | ANDA | Current |
| 0527-1369 | Danazol | Danazol | Lannett Company, Inc. | ANDA | Current |
| 68151-2298 | Danazol | Danazol | Carilion Materials Management | ANDA | Current |
| 71205-862 | Danazol | Danazol | Proficient Rx LP | ANDA | Current |