Application 019810
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRILOSEC | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | PRILOSEC | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | PRILOSEC | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63304-445 | Omeprazole Delayed-Release | Omeprazole | Ranbaxy Laboratories Inc. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 55458 | SUPPL | 2018-09-12 |
| 55457 | SUPPL | 2018-09-12 |
| 46476 | SUPPL | 2016-12-22 |
| 46492 | SUPPL | 2016-12-21 |
| 45716 | SUPPL | 2016-10-31 |
| 45656 | SUPPL | 2016-10-26 |
| 11734 | SUPPL | 2014-12-29 |
| 19246 | SUPPL | 2014-12-24 |
| 19245 | SUPPL | 2014-04-14 |
| 33972 | SUPPL | 2014-04-01 |
| 33973 | SUPPL | 2014-02-27 |
| 1637 | SUPPL | 2014-02-27 |
| 11733 | SUPPL | 2013-05-21 |
| 19244 | SUPPL | 2013-05-16 |
| 33971 | SUPPL | 2012-10-12 |
| 1636 | SUPPL | 2012-10-11 |
| 23139 | ORIG | 2012-10-03 |
| 19243 | SUPPL | 2012-10-02 |
| 11732 | SUPPL | 2012-10-01 |
| 33970 | SUPPL | 2012-02-06 |
| 1635 | SUPPL | 2012-01-24 |
| 23556 | ORIG | 2011-12-20 |
| 19240 | SUPPL | 2011-07-06 |
| 11729 | SUPPL | 2011-07-06 |
| 19242 | SUPPL | 2011-05-25 |
| 11731 | SUPPL | 2011-05-25 |
| 19241 | SUPPL | 2011-01-25 |
| 11730 | SUPPL | 2011-01-24 |
| 33969 | SUPPL | 2010-09-10 |
| 1634 | SUPPL | 2010-09-08 |
| 19239 | SUPPL | 2010-03-08 |
| 33968 | SUPPL | 2010-03-05 |
| 19238 | SUPPL | 2008-12-04 |
| 11728 | SUPPL | 2008-12-04 |
| 20367 | SUPPL | 2007-07-20 |
| 20361 | SUPPL | 2007-07-20 |
| 41036 | SUPPL | 2007-07-09 |
| 19237 | SUPPL | 2007-05-01 |
| 11727 | SUPPL | 2007-05-01 |
| 19236 | SUPPL | 2006-09-27 |
| 33967 | SUPPL | 2006-09-26 |
| 19235 | SUPPL | 2006-01-30 |
| 33966 | SUPPL | 2006-01-27 |
| 33965 | SUPPL | 2005-03-10 |
| 1633 | SUPPL | 2005-03-10 |
| 33961 | SUPPL | 2004-04-05 |
| 33960 | SUPPL | 2004-04-05 |
| 19230 | SUPPL | 2004-03-02 |
| 1631 | SUPPL | 2004-03-02 |
| 33964 | SUPPL | 2003-10-16 |
| 33962 | SUPPL | 2003-10-16 |
| 19234 | SUPPL | 2003-10-16 |
| 19231 | SUPPL | 2003-10-16 |
| 19233 | SUPPL | 2002-12-16 |
| 33963 | SUPPL | 2002-07-12 |
| 19232 | SUPPL | 2002-07-12 |
| 1632 | SUPPL | 2002-02-14 |
| 41037 | SUPPL | 2000-02-23 |
| 20366 | SUPPL | 1999-02-03 |
| 20365 | SUPPL | 1998-07-10 |
| 20363 | SUPPL | 1998-01-15 |
| 20364 | SUPPL | 1998-01-07 |
| 20362 | SUPPL | 1997-11-04 |