Manages pain severe enough to require an opioid analgesic. NDA 214044, held by Rosemont. Tramadol Hydrochloride.
As of Nov 13, 2026, NDA 214044 (Qdolo), held by Rosemont, was first approved by FDA on Sep 1, 2020, with 5 approved supplements and 0 published complete response letters.
Tramadol hydrochloride oral solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 1, 2020 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Qdolo5MG/ML · solution;oral | Tramadol Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 2026 | Supplement 5REMS | Approved | |
| Dec 22, 2025 | Supplement 4Labeling · Standard review | Approved | |
| Oct 31, 2024 | Supplement 3REMS | Approved | |
| Dec 15, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Sep 10, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Sep 1, 2020 | Original applicationNew dosage form · Standard 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
