Application 022020
- Type
- NDA
- Sponsor
- WYETH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROTONIX | PANTOPRAZOLE SODIUM | FOR SUSPENSION, DELAYED RELEASE;ORAL | EQ 40MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0008-0844 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0844 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0844 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0844 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 55154-4232 | Protonix | pantoprazole sodium | Cardinal Health | NDA | Current |
| 55154-4232 | Protonix | pantoprazole sodium | Cardinal Health 107, LLC | NDA | Current |
| 55154-4232 | Protonix | pantoprazole sodium | Cardinal Health | NDA | Current |
| 55154-4232 | Protonix | pantoprazole sodium | Cardinal Health | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74814 | SUPPL | 2023-07-20 |
| 74813 | SUPPL | 2023-07-20 |
| 74794 | SUPPL | 2023-07-19 |
| 70447 | SUPPL | 2022-03-09 |
| 70446 | SUPPL | 2022-03-09 |
| 70422 | SUPPL | 2022-03-07 |
| 65419 | SUPPL | 2020-11-30 |
| 65418 | SUPPL | 2020-11-30 |
| 65378 | SUPPL | 2020-11-30 |
| 60232 | SUPPL | 2019-10-04 |
| 60228 | SUPPL | 2019-10-04 |
| 58447 | SUPPL | 2019-04-26 |
| 58446 | SUPPL | 2019-04-26 |
| 58438 | SUPPL | 2019-04-26 |
| 54570 | SUPPL | 2018-06-14 |
| 54505 | SUPPL | 2018-06-11 |
| 50878 | SUPPL | 2017-12-27 |
| 50839 | SUPPL | 2017-12-22 |
| 48956 | SUPPL | 2017-07-12 |
| 48955 | SUPPL | 2017-07-12 |
| 48939 | SUPPL | 2017-07-10 |
| 45717 | SUPPL | 2016-10-31 |
| 45659 | SUPPL | 2016-10-26 |
| 38092 | SUPPL | 2014-12-29 |
| 29090 | SUPPL | 2014-12-24 |
| 29089 | SUPPL | 2013-12-13 |
| 16780 | SUPPL | 2013-12-11 |
| 16778 | SUPPL | 2012-10-15 |
| 29088 | SUPPL | 2012-10-11 |
| 16779 | SUPPL | 2012-05-15 |
| 23690 | ORIG | 2011-12-20 |
| 38091 | SUPPL | 2011-11-01 |
| 6697 | SUPPL | 2011-10-31 |
| 16777 | SUPPL | 2011-05-25 |
| 6698 | SUPPL | 2011-05-25 |
| 16776 | SUPPL | 2010-09-10 |
| 6696 | SUPPL | 2010-09-08 |
| 29087 | SUPPL | 2009-11-25 |
| 38090 | SUPPL | 2009-11-16 |
| 44664 | ORIG | 2009-03-31 |
| 42387 | ORIG | 2009-03-31 |
| 38089 | ORIG | 2007-11-19 |
| 6695 | ORIG | 2007-11-19 |
| 64042 | ORIG | 1900-01-01 |
| 64041 | ORIG | 1900-01-01 |
| 64040 | ORIG | 1900-01-01 |
| 64039 | ORIG | 1900-01-01 |
| 64038 | ORIG | 1900-01-01 |
| 58111 | ORIG | 1900-01-01 |
| 54079 | ORIG | 1900-01-01 |
| 53382 | ORIG | 1900-01-01 |
| 53381 | ORIG | 1900-01-01 |
| 53380 | ORIG | 1900-01-01 |
| 53379 | ORIG | 1900-01-01 |
| 53378 | ORIG | 1900-01-01 |