Application 022283
- Type
- NDA
- Sponsor
- BAYER HEALTHCARE LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZEGERID OTC | OMEPRAZOLE; SODIUM BICARBONATE | FOR SUSPENSION;ORAL | 20MG/PACKET;1.68GM/PACKET | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72719 | SUPPL | 2022-11-27 |
| 72699 | SUPPL | 2022-11-25 |
| 57527 | SUPPL | 2019-02-13 |
| 57295 | SUPPL | 2019-01-22 |
| 50363 | SUPPL | 2017-11-13 |
| 50309 | SUPPL | 2017-11-06 |
| 38495 | SUPPL | 2015-06-18 |
| 7168 | SUPPL | 2015-06-12 |
| 24273 | ORIG | 2014-12-09 |
| 21982 | ORIG | 2014-12-09 |
| 38494 | ORIG | 2013-09-24 |
| 7167 | ORIG | 2013-06-28 |