Application 020973
- Type
- NDA
- Sponsor
- EISAI INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACIPHEX | RABEPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | ACIPHEX | RABEPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | 20MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62856-243 | AcipHex | rabeprazole sodium | Eisai Inc. | NDA | Current |
| 62856-243 | AcipHex | rabeprazole sodium | Eisai Inc. | NDA | Current |
| 62856-243 | AcipHex | rabeprazole sodium | Eisai Inc. | NDA | Current |
| 62856-243 | AcipHex | rabeprazole sodium | Eisai Inc. | NDA | Current |
| 62856-243 | AcipHex | rabeprazole sodium | Eisai Inc. | NDA | Current |
| 62856-243 | AcipHex | rabeprazole sodium | Eisai Inc. | NDA | Current |
| 62856-243 | AcipHex | rabeprazole sodium | Eisai Inc. | NDA | Current |
| 62856-243 | AcipHex | rabeprazole sodium | Eisai Inc. | NDA | Current |
| 68151-3834 | AcipHex | rabeprazole sodium | Carilion Materials Management | NDA | Current |
| 69784-243 | Aciphex | rabeprazole sodium | Woodward Pharma Services LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74809 | SUPPL | 2023-07-20 |
| 74808 | SUPPL | 2023-07-20 |
| 74777 | SUPPL | 2023-07-19 |
| 70466 | SUPPL | 2022-03-10 |
| 70465 | SUPPL | 2022-03-10 |
| 70420 | SUPPL | 2022-03-07 |
| 70419 | SUPPL | 2022-03-07 |
| 65421 | SUPPL | 2020-11-30 |
| 65420 | SUPPL | 2020-11-30 |
| 65375 | SUPPL | 2020-11-30 |
| 54581 | SUPPL | 2018-06-14 |
| 54522 | SUPPL | 2018-06-11 |
| 54521 | SUPPL | 2018-06-11 |
| 51034 | SUPPL | 2018-01-11 |
| 51021 | SUPPL | 2018-01-10 |
| 47878 | SUPPL | 2017-04-06 |
| 45655 | SUPPL | 2016-10-26 |
| 3888 | SUPPL | 2016-04-06 |
| 35751 | SUPPL | 2016-04-05 |
| 14051 | SUPPL | 2014-12-29 |
| 3889 | SUPPL | 2014-12-24 |
| 26334 | SUPPL | 2014-10-21 |
| 35752 | SUPPL | 2014-10-16 |
| 14050 | SUPPL | 2013-04-23 |
| 3887 | SUPPL | 2013-04-23 |
| 26333 | SUPPL | 2012-10-10 |
| 35749 | SUPPL | 2012-10-09 |
| 35750 | SUPPL | 2012-05-10 |
| 3886 | SUPPL | 2012-05-10 |
| 21316 | SUPPL | 2012-03-02 |
| 44081 | ORIG | 2011-12-20 |
| 14049 | SUPPL | 2011-05-26 |
| 26332 | SUPPL | 2011-05-25 |
| 14048 | SUPPL | 2010-09-10 |
| 3885 | SUPPL | 2010-09-08 |
| 24185 | SUPPL | 2008-08-12 |
| 3884 | SUPPL | 2008-07-02 |
| 14047 | SUPPL | 2008-06-30 |
| 41850 | SUPPL | 2007-07-06 |
| 35748 | SUPPL | 2005-06-07 |
| 26331 | SUPPL | 2005-06-07 |
| 3883 | SUPPL | 2003-08-15 |
| 21317 | SUPPL | 2003-04-25 |
| 14045 | SUPPL | 2003-04-25 |
| 35747 | SUPPL | 2002-11-08 |
| 26329 | SUPPL | 2002-11-08 |
| 3882 | SUPPL | 2002-09-30 |
| 26330 | SUPPL | 2002-09-23 |
| 3881 | SUPPL | 2002-05-29 |
| 26328 | SUPPL | 2002-02-12 |
| 14046 | SUPPL | 2002-02-12 |
| 35746 | ORIG | 1999-08-19 |
| 26327 | ORIG | 1999-08-19 |
| 21315 | ORIG | 1999-08-19 |
| 63545 | SUPPL | 1900-01-01 |
| 63544 | SUPPL | 1900-01-01 |
| 58122 | ORIG | 1900-01-01 |
| 58121 | ORIG | 1900-01-01 |
| 58120 | ORIG | 1900-01-01 |
| 58119 | ORIG | 1900-01-01 |
| 58118 | ORIG | 1900-01-01 |
| 58117 | ORIG | 1900-01-01 |
| 58116 | ORIG | 1900-01-01 |
| 54127 | ORIG | 1900-01-01 |
| 54126 | ORIG | 1900-01-01 |