Application 022101
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEXIUM | ESOMEPRAZOLE MAGNESIUM | FOR SUSPENSION, DELAYED RELEASE;ORAL | EQ 10MG BASE/PACKET | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0186-4010 | NEXIUM | Esomeprazole magnesium | AstraZeneca Pharmaceutica | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 74838 | SUPPL | 2023-07-20 |
| 74837 | SUPPL | 2023-07-20 |
| 74800 | SUPPL | 2023-07-19 |
| 70460 | SUPPL | 2022-03-10 |
| 70459 | SUPPL | 2022-03-10 |
| 70413 | SUPPL | 2022-03-07 |
| 68491 | SUPPL | 2021-08-31 |
| 68490 | SUPPL | 2021-08-31 |
| 68479 | SUPPL | 2021-08-27 |
| 65411 | SUPPL | 2020-11-30 |
| 65410 | SUPPL | 2020-11-30 |
| 65381 | SUPPL | 2020-11-30 |
| 54567 | SUPPL | 2018-06-14 |
| 54502 | SUPPL | 2018-06-11 |
| 54499 | SUPPL | 2018-06-11 |
| 46481 | SUPPL | 2016-12-22 |
| 46485 | SUPPL | 2016-12-21 |
| 45694 | SUPPL | 2016-10-28 |
| 45661 | SUPPL | 2016-10-26 |
| 38240 | SUPPL | 2014-12-29 |
| 29243 | SUPPL | 2014-12-24 |
| 16932 | SUPPL | 2014-04-01 |
| 6881 | SUPPL | 2014-03-28 |
| 29242 | SUPPL | 2014-02-27 |
| 16933 | SUPPL | 2014-02-27 |
| 38239 | SUPPL | 2012-12-10 |
| 29241 | SUPPL | 2012-11-29 |
| 16931 | SUPPL | 2012-10-12 |
| 6880 | SUPPL | 2012-10-11 |
| 29240 | SUPPL | 2012-10-02 |
| 38238 | SUPPL | 2012-10-01 |
| 38237 | SUPPL | 2012-01-24 |
| 6879 | SUPPL | 2012-01-24 |
| 23698 | ORIG | 2011-12-20 |
| 38236 | SUPPL | 2011-07-06 |
| 29239 | SUPPL | 2011-07-06 |
| 38234 | SUPPL | 2011-06-29 |
| 6877 | SUPPL | 2011-06-27 |
| 38235 | SUPPL | 2010-09-10 |
| 6878 | SUPPL | 2010-09-09 |
| 44677 | ORIG | 2010-03-17 |
| 42413 | ORIG | 2010-03-17 |
| 29238 | SUPPL | 2010-03-08 |
| 38233 | SUPPL | 2010-03-05 |
| 29237 | SUPPL | 2009-11-25 |
| 38232 | SUPPL | 2009-10-14 |
| 29236 | SUPPL | 2009-01-21 |
| 16930 | SUPPL | 2009-01-16 |
| 6876 | ORIG | 2008-02-29 |
| 38231 | ORIG | 2008-02-28 |
| 53263 | ORIG | 1900-01-01 |
| 53262 | ORIG | 1900-01-01 |
| 53261 | ORIG | 1900-01-01 |