Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202686
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 20MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/17/2017 | ORIG-1 | Approval |
Label is not available on this site. |