Application 020059
- Type
- NDA
- Sponsor
- ASTELLAS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADENOSCAN | ADENOSINE | SOLUTION;INTRAVENOUS | 60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | ADENOSCAN | ADENOSINE | SOLUTION;INTRAVENOUS | 90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 34219 | SUPPL | 2014-08-22 |
| 34218 | SUPPL | 2014-08-22 |
| 21086 | SUPPL | 2014-08-21 |
| 1957 | SUPPL | 2014-08-21 |
| 21085 | SUPPL | 2014-01-07 |
| 12164 | SUPPL | 2014-01-07 |
| 23565 | ORIG | 2013-12-27 |
| 21084 | SUPPL | 2010-01-19 |
| 34217 | SUPPL | 2009-11-19 |
| 21083 | SUPPL | 2005-07-21 |
| 41137 | SUPPL | 2004-05-25 |
| 34216 | SUPPL | 2003-04-30 |
| 1956 | SUPPL | 2001-08-31 |