MEROPENEM | N202106 | B BRAUN MEDICAL INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Active | Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) | 39 | 2016-07 → 2026-12 | |
| Phase 4 | Recruiting | Rambam Health Care Campus | 1,084 | 2019-05-01 → 2027-04-01 | |
| Phase 2 | Completed | Pfizer | 83 | 2015-08-01 → 2017-06-01 | |
| Phase 2 | Completed | M.D. Anderson Cancer Center | 100 | 2018-05-16 → 2022-02-16 | |
| Phase 2 | Completed | Pfizer | 204 | 2009-03-31 → 2009-12-31 | |
| Phase 3 | Completed | PENTA Foundation | 272 | 2012-09 → 2014-12 | |
| Phase 1/2 | Completed | Benazir Bhutto Hospital, Rawalpindi | 90 | 2013-01 → 2013-12 | |
| Phase 3 | Completed | Mansoura University | 100 | 2013-08 → 2015-06 | |
| Phase 1 | Completed | Hoffmann-La Roche | 46 | 2016-10-31 → 2017-03-24 | |
| Phase 3 | Completed | Merck Sharp & Dohme LLC | 268 | 2019-03-20 → 2020-10-14 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
10 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| Date | Submission | Document |
|---|---|---|
| Dec 4, 2024 | SUPPL -9 | View Letter (PDF) |
| May 13, 2020 | SUPPL -7 | View Letter (PDF) |
| May 13, 2020 | SUPPL -7 | View Letter (PDF) |
| Jan 26, 2018 | SUPPL -3 | View Letter (PDF) |
| May 5, 2015 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.