Application 021287
- Type
- NDA
- Sponsor
- CONCORDIA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | UROXATRAL | ALFUZOSIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59212-200 | Uroxatral | Alfuzosin HCl | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-200 | Uroxatral | Alfuzosin HCl | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-200 | Uroxatral | Alfuzosin HCl | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-200 | Uroxatral | Alfuzosin HCl | Concordia Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63319 | SUPPL | 2020-05-28 |
| 63290 | SUPPL | 2020-05-26 |
| 54235 | SUPPL | 2018-05-17 |
| 54212 | SUPPL | 2018-05-16 |
| 27392 | SUPPL | 2014-08-06 |
| 14900 | SUPPL | 2014-04-22 |
| 14899 | SUPPL | 2013-06-04 |
| 27391 | SUPPL | 2013-05-31 |
| 4930 | SUPPL | 2010-12-21 |
| 14898 | SUPPL | 2010-12-16 |
| 14897 | SUPPL | 2010-04-19 |
| 27390 | SUPPL | 2010-04-13 |
| 27389 | SUPPL | 2009-05-27 |
| 14896 | SUPPL | 2009-05-25 |
| 51200 | SUPPL | 2008-10-17 |
| 27388 | SUPPL | 2008-09-23 |
| 14895 | SUPPL | 2008-09-19 |
| 4929 | SUPPL | 2008-05-09 |
| 4928 | SUPPL | 2007-04-09 |
| 14894 | SUPPL | 2007-03-31 |
| 42083 | SUPPL | 2007-01-10 |
| 27387 | SUPPL | 2006-11-22 |
| 14893 | SUPPL | 2006-11-22 |
| 51194 | SUPPL | 2006-06-15 |
| 4927 | SUPPL | 2006-03-23 |
| 14892 | SUPPL | 2006-03-22 |
| 51193 | SUPPL | 2006-02-21 |
| 42082 | ORIG | 2003-09-09 |
| 27386 | SUPPL | 2003-07-28 |
| 27385 | ORIG | 2003-06-22 |
| 14891 | ORIG | 2003-06-22 |
| 53168 | SUPPL | 1900-01-01 |
| 53167 | SUPPL | 1900-01-01 |
| 53166 | SUPPL | 1900-01-01 |