Application 206627
- Type
- NDA
- Sponsor
- PURDUE PHARMA LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYSINGLA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 20MG | Yes | Yes |
| 002 | HYSINGLA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 30MG | Yes | No |
| 003 | HYSINGLA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 40MG | Yes | No |
| 004 | HYSINGLA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 60MG | Yes | No |
| 005 | HYSINGLA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 80MG | Yes | No |
| 006 | HYSINGLA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Yes | No |
| 007 | HYSINGLA ER | HYDROCODONE BITARTRATE | TABLET, EXTENDED RELEASE;ORAL | 120MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59011-271 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-271 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-271 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-271 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-272 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-272 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-272 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-272 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-273 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-273 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-273 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-273 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-274 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-274 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-274 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-274 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-275 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-275 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-275 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-275 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-276 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-276 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-276 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-276 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-277 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-277 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-277 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
| 59011-277 | Hysingla ER | hydrocodone bitartrate | Purdue Pharma LP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84579 | SUPPL | 2025-12-29 |
| 80097 | SUPPL | 2024-11-04 |
| 77077 | SUPPL | 2023-12-19 |
| 77005 | SUPPL | 2023-12-19 |
| 76959 | SUPPL | 2023-12-18 |
| 66653 | SUPPL | 2021-03-08 |
| 66652 | SUPPL | 2021-03-08 |
| 66613 | SUPPL | 2021-03-08 |
| 60856 | SUPPL | 2019-11-15 |
| 60851 | SUPPL | 2019-11-15 |
| 60504 | SUPPL | 2019-10-09 |
| 60503 | SUPPL | 2019-10-09 |
| 60370 | SUPPL | 2019-10-08 |
| 55687 | SUPPL | 2018-10-01 |
| 55686 | SUPPL | 2018-10-01 |
| 55539 | SUPPL | 2018-09-21 |
| 55538 | SUPPL | 2018-09-21 |
| 48588 | SUPPL | 2017-05-31 |
| 46443 | SUPPL | 2016-12-21 |
| 46319 | SUPPL | 2016-12-20 |
| 45452 | SUPPL | 2016-10-03 |
| 32822 | SUPPL | 2016-04-22 |
| 24129 | ORIG | 2015-11-04 |
| 32821 | SUPPL | 2015-07-08 |
| 43525 | ORIG | 2015-04-07 |
| 24521 | ORIG | 2015-04-07 |
| 24130 | ORIG | 2014-12-11 |
| 44433 | ORIG | 2014-11-20 |
| 43559 | ORIG | 2014-11-20 |
| 40563 | ORIG | 2014-11-20 |
| 32820 | ORIG | 2014-11-20 |
| 84630 | SUPPL |