NDA 50824, held by Cumberland. Amoxicillin; Clarithromycin; Omeprazole.
As of Nov 13, 2026, NDA 50824 (Omeclamox-Pak), held by Cumberland, was first approved by FDA on Feb 8, 2011, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 8, 2011 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omeclamox-Pak500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, tablet, capsule, delayed release;oral | Amoxicillin; Clarithromycin; Omeprazole | DiscontinuedReference drug |
| May 1, 2024 | Supplement 13Labeling · Standard review | Approved | |
| Aug 16, 2023 | Supplement 11Labeling · Standard review | Approved | |
| Aug 16, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Mar 4, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Nov 27, 2020 | Supplement 9Labeling · Standard review | Approved | |
| Jan 17, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Oct 24, 2016 | Supplement 6Labeling | Approved | |
| Feb 26, 2016 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 29, 2014 | Supplement 4Labeling | Approved | |
| Sep 7, 2011 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 8, 2011 | 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
