Application 022519
- Type
- NDA
- Sponsor
- HORIZON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DUEXIS | FAMOTIDINE; IBUPROFEN | TABLET;ORAL | 26.6MG;800MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70748-312 | Ibuprofen and Famotidine | Ibuprofen and Famotidine | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-312 | Ibuprofen and Famotidine | Ibuprofen and Famotidine | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-312 | Ibuprofen and Famotidine | Ibuprofen and Famotidine | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 75987-010 | DUEXIS | Ibuprofen and Famotidine | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-010 | DUEXIS | Ibuprofen and Famotidine | Horizon Pharma Inc. | NDA | Current |
| 75987-010 | DUEXIS | Ibuprofen and Famotidine | Horizon Medicines LLC | NDA | Current |
| 75987-010 | DUEXIS | Ibuprofen and Famotidine | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-010 | DUEXIS | Ibuprofen and Famotidine | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-010 | DUEXIS | Ibuprofen and Famotidine | Horizon Therapeutics USA, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80414 | SUPPL | 2024-11-25 |
| 80413 | SUPPL | 2024-11-25 |
| 80312 | SUPPL | 2024-11-22 |
| 67364 | SUPPL | 2021-05-03 |
| 67363 | SUPPL | 2021-05-03 |
| 67284 | SUPPL | 2021-04-30 |
| 59419 | SUPPL | 2019-07-23 |
| 59404 | SUPPL | 2019-07-23 |
| 59403 | SUPPL | 2019-07-23 |
| 48675 | SUPPL | 2017-06-08 |
| 48674 | SUPPL | 2017-06-07 |
| 48673 | SUPPL | 2017-06-07 |
| 38806 | SUPPL | 2016-05-11 |
| 7495 | SUPPL | 2016-05-10 |
| 42547 | ORIG | 2011-11-02 |
| 24330 | ORIG | 2011-11-02 |
| 29822 | ORIG | 2011-04-28 |
| 17674 | ORIG | 2011-04-26 |