Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216247
Company: DEXCEL
Company: DEXCEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | 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 |
---|---|---|---|---|---|---|---|
06/16/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/05/2024 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
04/05/2024 | SUPPL-1 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
PANTOPRAZOLE SODIUM
FOR SUSPENSION, DELAYED RELEASE;ORAL; EQ 40MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | No | AB | 217416 | AJANTA PHARMA LTD |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | No | AB | 216139 | ANNORA PHARMA |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | No | AB | 216247 | DEXCEL |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | No | AB | 213725 | SUN PHARM |
PROTONIX | PANTOPRAZOLE SODIUM | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 022020 | WYETH PHARMS |