Application 077249
- Type
- ANDA
- Sponsor
- ROXANE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXANDROLONE | OXANDROLONE | TABLET;ORAL | 2.5MG | No | No |
| 002 | OXANDROLONE | OXANDROLONE | TABLET;ORAL | 10MG | No | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.