Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217264
Company: MARKSANS PHARMA
Company: MARKSANS PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE;ORAL | Over-the-counter | 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 |
|---|---|---|---|---|---|---|---|
| 09/29/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ESOMEPRAZOLE MAGNESIUM
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE, DELAYED RELEASE;ORAL; EQ 20MG BASE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE;ORAL | Over-the-counter | No | 217264 | MARKSANS PHARMA |