Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203024
Company: L PERRIGO CO
Company: L PERRIGO CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, 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 |
|---|---|---|---|---|---|---|---|
| 05/07/2014 | ORIG-1 | Approval |
Label is not available on this site. |
PANTOPRAZOLE SODIUM
TABLET, DELAYED RELEASE;ORAL; EQ 20MG 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 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090797 | ACTAVIS TOTOWA |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205119 | AMNEAL PHARMS |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091231 | ATLANTIDE |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202038 | AUROBINDO PHARMA LTD |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077619 | DR REDDYS LABS LTD |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202882 | HETERO LABS LTD V |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 203024 | L PERRIGO CO |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078281 | LANNETT CO INC |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090970 | MYLAN PHARMS INC |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202052 | ORBION PHARMS |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090807 | RUBICON |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090074 | TORRENT PHARMS |
| PROTONIX | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 020987 | WYETH PHARMS |
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