Application 007337
- Type
- NDA
- Sponsor
- ENDO PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 005 | PERCODAN-DEMI | ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE | TABLET;ORAL | 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 006 | PERCODAN | ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE | TABLET;ORAL | 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 007 | PERCODAN | ASPIRIN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;4.8355MG | Yes | Yes |
Documents
| Document | Submission type | Date |
|---|---|---|
| 84697 | SUPPL | 2026-01-06 |
| 84696 | SUPPL | 2026-01-06 |
| 84549 | SUPPL | 2025-12-29 |
| 80334 | SUPPL | 2024-11-25 |
| 80281 | SUPPL | 2024-11-22 |
| 80068 | SUPPL | 2024-11-04 |
| 78203 | SUPPL | 2024-04-23 |
| 78184 | SUPPL | 2024-04-22 |
| 76877 | SUPPL | 2023-12-18 |
| 76223 | ORIG | 2023-11-03 |
| 67222 | SUPPL | 2021-04-29 |
| 67220 | SUPPL | 2021-04-29 |
| 67215 | SUPPL | 2021-04-29 |
| 60323 | SUPPL | 2019-10-08 |
| 60305 | SUPPL | 2019-10-08 |
| 60302 | SUPPL | 2019-10-08 |
| 55825 | SUPPL | 2018-10-05 |
| 55824 | SUPPL | 2018-10-05 |
| 55823 | SUPPL | 2018-10-05 |
| 55822 | SUPPL | 2018-10-05 |
| 55649 | SUPPL | 2018-09-28 |
| 55648 | SUPPL | 2018-09-28 |
| 46560 | SUPPL | 2016-12-27 |
| 46417 | SUPPL | 2016-12-21 |
| 46199 | SUPPL | 2016-12-19 |
| 10693 | SUPPL | 2010-07-31 |
| 37 | SUPPL | 2010-07-30 |
| 10692 | SUPPL | 2010-03-18 |
| 87 | SUPPL | 2010-03-18 |
| 36 | SUPPL | 2006-08-21 |
| 10691 | SUPPL | 2006-08-14 |
| 10690 | SUPPL | 2004-06-15 |
| 35 | SUPPL | 2004-06-15 |
| 40649 | SUPPL | 2003-08-08 |