Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020987
Company: WYETH PHARMS
Company: WYETH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROTONIX | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| PROTONIX | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 02/02/2000 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20987lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20987ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20987_Protonix.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020987s060,022020s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020987Orig1s060;022020Orig1s023ltr.pdf | |
| 03/04/2022 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020987Orig1s058; 022020Orig1s021ltr.pdf | |
| 11/27/2020 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020987s056,022020s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020987Orig1s056;022020Orig1s018ltr.pdf | |
| 04/25/2019 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020987s055,022020s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020987Orig1s055; 020988Orig1s061; 022020Orig1s017ltr.pdf | |
| 06/07/2018 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020987s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020987Orig1s054,022020Orig1s016,020988Orig1s060ltr.pdf | |
| 07/06/2017 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020987Origs053,022020Orig1s015ltr.pdf | |
| 12/06/2017 | SUPPL-52 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022020s014,020987s052,020988s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022020s014, 020987s052, 020988s058ltr.pdf | |
| 12/20/2017 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s051,022020s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020987Orig1s051,020988Orig1s055,022020Orig1s013ltr.pdf | |
| 10/24/2016 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020987s050,022020s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020987Orig1s050,022020Orig1s012ltr.pdf | |
| 12/19/2014 | SUPPL-49 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022020Orig1s011,020987Orig1s049ltr.pdf | |
| 12/10/2013 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020987s048,022020s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020987Orig1s048,022020Orig1s010ltr.pdf | |
| 01/25/2013 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/2012 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s045lbl.pdf | |
| 10/09/2012 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020987Orig1s043,022020Orig1s006ltr.pdf | |
| 05/20/2011 | SUPPL-41 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020987s041,022020s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020987s041,022020s005ltr.pdf | |
| 10/31/2011 | SUPPL-39 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022020s004,020987s039ltr.pdf | |
| 09/03/2010 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020987s038,022020s003ltr.pdf | |
| 11/12/2009 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022020s002,020987s036,s037ltr.pdf | |
| 11/12/2009 | SUPPL-36 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022020s002,020987s036,s037ltr.pdf | |
| 12/20/2007 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020987s035,020988s038rev2_dw.pdf |
| 07/25/2006 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020987s032LTR.pdf |
| 11/18/2004 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987s026ltr.pdf |
| 03/12/2004 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr023ltr.pdf | |
| 01/09/2004 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr022_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr022ltr.pdf | |
| 12/30/2003 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20987slr021ltr.pdf |
| 05/05/2004 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr020_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr020ltr.pdf | |
| 03/05/2004 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr017ltr.pdf | |
| 12/04/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/2002 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/2002 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987slr013,20988slr012ltr.pdf |
| 07/22/2002 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/2002 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20987s7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987s007.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-987s007_Protonix.cfm | |
| 06/12/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/2001 | SUPPL-5 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20987s5lbl.pdf | |
| 05/21/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/19/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2001 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20987S1S2ltr.pdf |
| 06/12/2001 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/020987S1S2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20987S1S2ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2023 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020987s060,022020s023lbl.pdf | |
| 03/04/2022 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf | |
| 11/27/2020 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020987s056,022020s018lbl.pdf | |
| 04/25/2019 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020987s055,022020s017lbl.pdf | |
| 06/07/2018 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020987s054lbl.pdf | |
| 12/20/2017 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s051,022020s013lbl.pdf | |
| 12/06/2017 | SUPPL-52 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022020s014,020987s052,020988s058lbl.pdf | |
| 07/06/2017 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf | |
| 10/24/2016 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020987s050,022020s012lbl.pdf | |
| 12/19/2014 | SUPPL-49 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf | |
| 12/19/2014 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf | |
| 12/10/2013 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020987s048,022020s010lbl.pdf | |
| 10/09/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.pdf | |
| 05/11/2012 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s045lbl.pdf | |
| 10/31/2011 | SUPPL-39 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.pdf | |
| 05/20/2011 | SUPPL-41 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020987s041,022020s005lbl.pdf | |
| 09/03/2010 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.pdf | |
| 11/12/2009 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf | |
| 11/12/2009 | SUPPL-36 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf | |
| 05/05/2004 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr020_protonix_lbl.pdf | |
| 03/12/2004 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf | |
| 03/05/2004 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf | |
| 01/09/2004 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr022_protonix_lbl.pdf | |
| 04/19/2002 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20987s7lbl.pdf | |
| 07/20/2001 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20987s5lbl.pdf | |
| 06/12/2001 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/020987S1S2lbl.pdf | |
| 02/02/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20987lbl.pdf |
PROTONIX
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 | 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 | 217282 | GRANULES |
| 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 | 078281 | LANNETT CO INC |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 215880 | MANKIND PHARMA |
| 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 | ORBION PHARMS |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090807 | RUBICON |
| 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 BIO AG |
| PROTONIX | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 020987 | WYETH PHARMS |
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 | 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 | 217282 | GRANULES |
| 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 | 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 |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091231 | WOCKHARDT BIO AG |
| PROTONIX | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 020987 | WYETH PHARMS |