ESOMEPRAZOLE MAGNESIUM | N214278 | DEXCEL PHARMA TECHNOLOGIES LTD
30 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 |
|---|---|---|
| May 12, 2022 | SUPPL -2 | View Letter (PDF) |
| Sep 9, 2021 | SUPPL -1 | View Letter (PDF) |
| Oct 21, 2020 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.