Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200882
Company: SUN PHARM
Company: SUN PHARM
| 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 |
|---|---|---|---|---|---|---|---|
| 03/18/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/14/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/14/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |