Application 022281
- Type
- NDA
- Sponsor
- BAYER HEALTHCARE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZEGERID OTC | OMEPRAZOLE; SODIUM BICARBONATE | CAPSULE;ORAL | 20MG;1.1GM | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 11523-7265 | Zegerid OTC | Omeprazole and Sodium Bicarbonate | Bayer HealthCare LLC | NDA | Current |
| 11523-7265 | Zegerid OTC | Omeprazole and Sodium Bicarbonate | Bayer HealthCare LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84333 | SUPPL | 2025-11-28 |
| 84325 | SUPPL | 2025-11-28 |
| 78018 | SUPPL | 2024-04-01 |
| 78017 | SUPPL | 2024-04-01 |
| 72907 | SUPPL | 2022-12-15 |
| 72879 | SUPPL | 2022-12-14 |
| 72571 | SUPPL | 2022-11-07 |
| 72533 | SUPPL | 2022-11-02 |
| 57294 | SUPPL | 2019-01-22 |
| 57251 | SUPPL | 2019-01-18 |
| 50316 | SUPPL | 2017-11-07 |
| 50297 | SUPPL | 2017-11-06 |
| 47272 | SUPPL | 2017-02-21 |
| 47267 | SUPPL | 2017-02-21 |
| 17195 | SUPPL | 2015-07-10 |
| 29521 | SUPPL | 2015-06-11 |
| 17194 | SUPPL | 2014-01-15 |
| 7166 | SUPPL | 2012-09-24 |
| 17193 | SUPPL | 2012-03-27 |
| 23706 | ORIG | 2011-12-20 |
| 7165 | SUPPL | 2011-07-28 |
| 29520 | SUPPL | 2010-12-22 |
| 29519 | SUPPL | 2010-12-22 |
| 29518 | SUPPL | 2010-04-28 |
| 21981 | ORIG | 2010-02-23 |
| 17192 | ORIG | 2009-12-04 |
| 29517 | ORIG | 2009-12-02 |