Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214473
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, 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 |
---|---|---|---|---|---|---|---|
07/12/2023 | 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.
TABLET, 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 | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 214473 | AUROBINDO PHARMA LTD |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 211571 | DR REDDYS |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | No | 212088 | MYLAN |
NEXIUM 24HR | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Over-the-counter | Yes | 207920 | ASTRAZENECA LP |