Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207181
Company: DEVA HOLDING AS
Company: DEVA HOLDING AS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
03/06/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ESOMEPRAZOLE SODIUM
INJECTABLE;INTRAVENOUS; EQ 40MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207181 | DEVA HOLDING AS |
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204657 | EUGIA PHARMA |
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 203349 | GLAND PHARMA LTD |
ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 215732 | SLATE RUN PHARMA |