Manages severe and persistent pain. NDA 206627, held by Knoa Pharma. Hydrocodone Bitartrate.
As of Nov 14, 2026, NDA 206627 (Hysingla Er), held by Knoa Pharma, was first approved by FDA on Nov 20, 2014, with 14 approved supplements and 0 published complete response letters.
HYSINGLA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including HYSINGLA ER, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. HYSINGLA ER is not indicated as an as-needed (prn) analgesic.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2014 | Original applicationNew dosage form · Priority review | Approved |
| Hysingla Er20MG · tablet, extended release;oral | Hydrocodone Bitartrate | RxReference drug |
| Hysingla Er30MG · tablet, extended release;oral | Hydrocodone Bitartrate | RxReference drug |
| Hysingla Er40MG · tablet, extended release;oral | Hydrocodone Bitartrate | RxReference drug |
| Hysingla Er60MG · tablet, extended release;oral | Hydrocodone Bitartrate | RxReference drug |
| Hysingla Er80MG · tablet, extended release;oral | Hydrocodone Bitartrate | RxReference drug |
| Hysingla Er100MG · tablet, extended release;oral | Hydrocodone Bitartrate | RxReference drug |
| Hysingla Er120MG · tablet, extended release;oral | Hydrocodone Bitartrate | DiscontinuedReference drug |
| Jun 18, 2026 | Supplement 18REMS | Approved | |
| Dec 22, 2025 | Supplement 17Labeling · Standard review | Approved | |
| Oct 31, 2024 | Supplement 16REMS | Approved | |
| Dec 15, 2023 | Supplement 15Labeling · Standard review | Approved | |
| Mar 4, 2021 | Supplement 12Labeling · Standard review | Approved | |
| Nov 14, 2019 | Supplement 9REMS | Approved | |
| Oct 7, 2019 | Supplement 10Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 8Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 7REMS | Approved | |
| May 26, 2017 | Supplement 6REMS | Approved | |
| Dec 16, 2016 | Supplement 4Labeling · Standard review | Approved | |
| Sep 30, 2016 | Supplement 5REMS | Approved | |
| Apr 20, 2016 | Supplement 3REMS | Approved | |
| Jun 26, 2015 | Supplement 1REMS | Approved | |
| Nov 20, 2014 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
