Manages acute pain severe enough to require an opioid analgesic. ANDA 76642, held by Amneal Pharms Ny. Hydrocodone Bitartrate; Ibuprofen.
As of Nov 15, 2026, ANDA 76642 (Hydrocodone Bitartrate And Ibuprofen), held by Amneal Pharms Ny, was first approved by FDA on Mar 18, 2004, with 27 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2004 | Original application | Approved |
| Hydrocodone Bitartrate And Ibuprofen7.5MG;200MG · tablet;oral | Hydrocodone Bitartrate; Ibuprofen | Rx |
| Hydrocodone Bitartrate And Ibuprofen5MG;200MG · tablet;oral | Hydrocodone Bitartrate; Ibuprofen | Rx |
| Hydrocodone Bitartrate And Ibuprofen2.5MG;200MG · tablet;oral | Hydrocodone Bitartrate; Ibuprofen | Discontinued |
| Hydrocodone Bitartrate And Ibuprofen10MG;200MG · tablet;oral | Hydrocodone Bitartrate; Ibuprofen | Rx |
| Jun 18, 2026 | Supplement 49REMS | Approved | None posted |
| Dec 22, 2025 | Supplement 48Labeling · Standard review | Approved | None posted |
| Nov 21, 2024 | Supplement 47Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 45REMS | Approved | None posted |
| Oct 3, 2024 | Supplement 44Labeling · Standard review | Approved | None posted |
| Dec 18, 2023 | Supplement 41Labeling · Standard review | Approved | None posted |
| Dec 18, 2023 | Supplement 42Labeling · Standard review | Approved | None posted |
| Dec 15, 2023 | Supplement 35Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 32Labeling · Standard review | Approved | None posted |
| Mar 4, 2021 | Supplement 30Labeling · Standard review | Approved | None posted |
| Oct 10, 2019 | Supplement 28Labeling · Standard review | Approved | None posted |
| Jul 22, 2019 | Supplement 27Labeling · Standard review | Approved | None posted |
| Sep 21, 2018 | Supplement 24Labeling · Standard review | Approved | None posted |
| Sep 18, 2018 | Supplement 25REMS | Approved | None posted |
| Aug 15, 2018 | Supplement 20Labeling · Standard review | Approved | None posted |
| Aug 15, 2018 | Supplement 22Labeling · Standard review | Approved | None posted |
| Aug 15, 2018 | Supplement 23Labeling · Standard review | Approved | None posted |
| Mar 20, 2008 | Supplement 11Manufacturing | Approved | None posted |
| Oct 19, 2007 | Supplement 5Manufacturing | Approved | |
| Oct 19, 2007 | Supplement 6Labeling | Approved | |
| Oct 19, 2007 | Supplement 7Manufacturing | Approved | |
| Oct 19, 2007 | Supplement 8Labeling | Approved | |
| Jan 4, 2007 | Supplement 10Labeling | Approved | None posted |
| Jan 3, 2007 | Supplement 9Labeling | Approved | None posted |
| Oct 12, 2004 | Supplement 3 | Approved | None posted |
| Jun 16, 2004 | Supplement 2Labeling | Approved | None posted |
| Apr 5, 2004 | Supplement 1Labeling | Approved | None posted |
| Mar 18, 2004 | Original application | 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
