Application 020975
- Type
- NDA
- Sponsor
- LIEBEL-FLARSHEIM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OPTIMARK | GADOVERSETAMIDE | INJECTABLE;INJECTION | 16.545GM/50ML (330.9MG/ML) | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56432 | SUPPL | 2018-11-14 |
| 56288 | SUPPL | 2018-11-06 |
| 56287 | SUPPL | 2018-11-06 |
| 53897 | SUPPL | 2018-05-01 |
| 53842 | SUPPL | 2018-04-27 |
| 53841 | SUPPL | 2018-04-27 |
| 45221 | SUPPL | 2016-08-29 |
| 14057 | SUPPL | 2014-11-26 |
| 3899 | SUPPL | 2014-11-26 |
| 26340 | SUPPL | 2014-08-11 |
| 35757 | SUPPL | 2014-08-08 |
| 26339 | SUPPL | 2013-08-27 |
| 14056 | SUPPL | 2013-08-27 |
| 35756 | SUPPL | 2013-05-23 |
| 3898 | SUPPL | 2013-05-23 |
| 3897 | SUPPL | 2010-12-22 |
| 14055 | SUPPL | 2010-12-20 |
| 14053 | SUPPL | 2008-08-26 |
| 3895 | SUPPL | 2008-08-20 |
| 14054 | SUPPL | 2007-09-06 |
| 3896 | SUPPL | 2007-09-06 |
| 35755 | SUPPL | 2006-08-07 |
| 3894 | SUPPL | 2006-08-07 |
| 44083 | ORIG | 2006-06-09 |
| 26338 | SUPPL | 2005-11-30 |
| 14052 | SUPPL | 2004-06-10 |
| 3893 | SUPPL | 2004-06-10 |
| 41852 | SUPPL | 2004-01-29 |
| 35754 | ORIG | 1999-12-08 |
| 26337 | ORIG | 1999-12-08 |
| 21319 | ORIG | 1999-12-08 |