Application 013718
- Type
- NDA
- Sponsor
- GEMINI LABS LLC
Application Products#
| 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 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N013718-001 | OXANDRIN | 2.5MG | TABLET / ORAL | RLD, Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N013718-002 | OXANDRIN | 10MG | TABLET / ORAL | RLD | 2001-11-05 | cb3db0bc1861… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.