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Application 021711
- Type
- NDA
- Sponsor
- LANTHEUS MEDCL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ABLAVAR | GADOFOSVESET TRISODIUM | SOLUTION;INTRAVENOUS | 2440MG/10ML (244MG/ML) | No | No |
| 002 | ABLAVAR | GADOFOSVESET TRISODIUM | SOLUTION;INTRAVENOUS | 3660MG/15ML (244MG/ML) | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 16237 | SUPPL | 2013-08-09 |
| 6027 | SUPPL | 2013-08-08 |
| 23672 | ORIG | 2011-12-21 |
| 28433 | SUPPL | 2010-12-22 |
| 37498 | SUPPL | 2010-12-20 |
| 37497 | SUPPL | 2010-01-29 |
| 28432 | SUPPL | 2010-01-15 |
| 44643 | ORIG | 2009-04-02 |
| 21784 | ORIG | 2009-03-31 |
| 28431 | ORIG | 2009-01-02 |