Application 016848
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ANADROL-50 | OXYMETHOLONE | TABLET;ORAL | 50MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68220-055 | Anadrol-50 | oxymetholone | Alaven Pharmaceutical LLC | NDA | Current |
| 68220-055 | Anadrol-50 | oxymetholone | Alaven Pharmaceutical | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 33203 | SUPPL | 2004-08-31 |
| 13042 | SUPPL | 2004-08-31 |
| 13041 | SUPPL | 2003-11-25 |