Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 077056
Company: TEVA
Company: TEVA
| 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 |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG 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 |
|---|---|---|---|---|---|---|---|
| 08/02/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077056ltrTA.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/08/2015 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/03/2013 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/03/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/03/2012 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2011 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/31/2011 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/31/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2009 | SUPPL-3 | Labeling |
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 | 090807 | APOTEX INC |
| 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 | 090901 | JUBILANT GENERICS |
| 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 | 200821 | MACLEODS PHARMS LTD |
| 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 | ORCHID HLTHCARE |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077056 | TEVA |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090074 | TORRENT PHARMS |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091231 | WOCKHARDT |
| PROTONIX | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 020987 | WYETH PHARMS |
TABLET, 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 | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090797 | ACTAVIS TOTOWA |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205119 | AMNEAL PHARMS |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090807 | APOTEX INC |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202038 | AUROBINDO PHARMA LTD |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077619 | DR REDDYS LABS LTD |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202882 | HETERO LABS LTD V |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 211368 | INGENUS PHARMS LLC |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090901 | JUBILANT GENERICS |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078281 | LANNETT CO INC |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200821 | MACLEODS PHARMS LTD |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090970 | MYLAN PHARMS INC |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202052 | ORCHID HLTHCARE |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 077056 | TEVA |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090074 | TORRENT PHARMS |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091231 | WOCKHARDT |
| PROTONIX | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 020987 | WYETH PHARMS |
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