Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211752
Company: CIPLA
Company: CIPLA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 10MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 03/23/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211752Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/11/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
ESOMEPRAZOLE MAGNESIUM
FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 10MG BASE/PACKET
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 10MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | No | AB | 211752 | CIPLA |
| NEXIUM | ESOMEPRAZOLE MAGNESIUM | EQ 10MG BASE/PACKET | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 022101 | ASTRAZENECA |