Application 202080
- Type
- NDA
- Sponsor
- ZYLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXAYDO | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | OXAYDO | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 7.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69344-113 | OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-113 | OXAYDO | OXYCODONE HYDROCHLORIDE | Egalet US Inc. | NDA | Current |
| 69344-113 | OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-113 | OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-113 | OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-113 | OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-213 | OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-213 | OXAYDO | OXYCODONE HYDROCHLORIDE | Egalet US Inc. | NDA | Current |
| 69344-213 | OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-213 | OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-213 | OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-213 | OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84676 | SUPPL | 2026-01-06 |
| 84572 | SUPPL | 2025-12-29 |
| 80083 | SUPPL | 2024-11-04 |
| 78231 | SUPPL | 2024-04-24 |
| 78225 | SUPPL | 2024-04-24 |
| 78190 | SUPPL | 2024-04-19 |
| 77073 | SUPPL | 2023-12-19 |
| 76964 | SUPPL | 2023-12-18 |
| 76244 | ORIG | 2023-11-03 |
| 66633 | SUPPL | 2021-03-08 |
| 66632 | SUPPL | 2021-03-08 |
| 66575 | SUPPL | 2021-03-08 |
| 60407 | SUPPL | 2019-10-09 |
| 60404 | SUPPL | 2019-10-09 |
| 60405 | SUPPL | 2019-10-07 |
| 55718 | SUPPL | 2018-10-01 |
| 55717 | SUPPL | 2018-10-01 |
| 55568 | SUPPL | 2018-09-24 |
| 55567 | SUPPL | 2018-09-24 |
| 55566 | SUPPL | 2018-09-24 |
| 55565 | SUPPL | 2018-09-24 |
| 46594 | SUPPL | 2016-12-29 |
| 46426 | SUPPL | 2016-12-21 |
| 46425 | SUPPL | 2016-12-21 |
| 46306 | SUPPL | 2016-12-20 |
| 46305 | SUPPL | 2016-12-20 |
| 40110 | SUPPL | 2015-02-13 |
| 32169 | SUPPL | 2015-01-27 |
| 32168 | SUPPL | 2014-01-17 |
| 19052 | SUPPL | 2014-01-17 |
| 9949 | SUPPL | 2013-06-04 |
| 40109 | SUPPL | 2013-06-03 |
| 43381 | ORIG | 2012-02-10 |
| 32167 | ORIG | 2011-06-28 |
| 19051 | ORIG | 2011-06-27 |