Application 020937
- Type
- NDA
- Sponsor
- LIEBEL-FLARSHEIM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OPTIMARK | GADOVERSETAMIDE | INJECTABLE;INJECTION | 1654.5MG/5ML (330.9MG/ML) | Yes | No |
| 002 | OPTIMARK | GADOVERSETAMIDE | INJECTABLE;INJECTION | 3309MG/10ML (330.9MG/ML) | Yes | No |
| 003 | OPTIMARK | GADOVERSETAMIDE | INJECTABLE;INJECTION | 4963.5MG/15ML (330.9MG/ML) | Yes | No |
| 004 | OPTIMARK | GADOVERSETAMIDE | INJECTABLE;INJECTION | 6618MG/20ML (330.9MG/ML) | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56431 | SUPPL | 2018-11-14 |
| 56291 | SUPPL | 2018-11-06 |
| 56286 | SUPPL | 2018-11-06 |
| 53896 | SUPPL | 2018-05-01 |
| 53840 | SUPPL | 2018-04-27 |
| 53837 | SUPPL | 2018-04-27 |
| 45222 | SUPPL | 2016-08-29 |
| 26246 | SUPPL | 2014-11-26 |
| 13780 | SUPPL | 2014-11-26 |
| 3807 | SUPPL | 2014-08-11 |
| 35677 | SUPPL | 2014-08-08 |
| 26245 | SUPPL | 2013-08-27 |
| 13779 | SUPPL | 2013-08-27 |
| 35676 | SUPPL | 2013-05-23 |
| 26244 | SUPPL | 2013-05-23 |
| 26243 | SUPPL | 2010-12-22 |
| 13778 | SUPPL | 2010-12-20 |
| 35675 | SUPPL | 2007-09-06 |
| 26242 | SUPPL | 2007-09-06 |
| 35674 | SUPPL | 2006-08-07 |
| 3806 | SUPPL | 2006-08-07 |
| 44080 | ORIG | 2006-06-09 |
| 3805 | SUPPL | 2005-11-30 |
| 26241 | SUPPL | 2004-06-10 |
| 13777 | SUPPL | 2004-06-10 |
| 41825 | SUPPL | 2004-01-29 |
| 35673 | ORIG | 1999-12-08 |
| 26240 | ORIG | 1999-12-08 |
| 21290 | ORIG | 1999-12-08 |