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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077249-001 | OXANDROLONE | 2.5MG | TABLET / ORAL | 2007-07-10 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077249-002 | OXANDROLONE | 10MG | TABLET / ORAL | 2007-07-10 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.