Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202686
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| 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. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/11/2024 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/11/2024 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/11/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/11/2024 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 10/11/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |