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Application 013718
- Type
- NDA
- Sponsor
- GEMINI LABS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXANDRIN | OXANDROLONE | TABLET;ORAL | 2.5MG | Yes | No |
| 002 | OXANDRIN | OXANDROLONE | TABLET;ORAL | 10MG | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 40692 | SUPPL | 2006-10-25 |
| 10835 | SUPPL | 2005-06-21 |
| 367 | SUPPL | 2005-06-21 |
| 33109 | SUPPL | 2003-06-10 |
| 10834 | SUPPL | 2003-06-10 |
| 12055 | SUPPL | 2003-05-29 |
| 33110 | SUPPL | 2003-05-28 |
| 12054 | SUPPL | 2001-11-05 |
| 366 | SUPPL | 2001-11-05 |