Manages acute pain severe enough to require an opioid analgesic. NDA 208653, held by Zevra Therap. Acetaminophen; Benzhydrocodone Hydrochloride.
As of Nov 13, 2026, NDA 208653 (Apadaz), held by Zevra Therap, was first approved by FDA on Feb 23, 2018, with 6 approved supplements and 0 published complete response letters.
APADAZ is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2018 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Apadaz325MG;EQ 6.12MG BASE · tablet;oral | Acetaminophen; Benzhydrocodone Hydrochloride | DiscontinuedReference drug |
| Apadaz325MG;EQ 4.08MG BASE · tablet;oral | Acetaminophen; Benzhydrocodone Hydrochloride | DiscontinuedReference drug |
| Apadaz325MG;EQ 8.16MG BASE · tablet;oral | Acetaminophen; Benzhydrocodone Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 2024 | Supplement 9REMS | Approved | |
| Dec 15, 2023 | Supplement 8Labeling · Standard review | Approved | |
| Mar 4, 2021 | Supplement 7Labeling · Standard review | Approved | |
| Oct 7, 2019 | Supplement 5Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 3REMS | Approved | |
| Feb 23, 2018 | Original applicationNew combination · 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
