Application 021358
- Type
- NDA
- Sponsor
- BRACCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MULTIHANCE MULTIPACK | GADOBENATE DIMEGLUMINE | INJECTABLE;INTRAVENOUS | 26.45GM/50ML (529MG/ML) | Yes | Yes |
| 002 | MULTIHANCE MULTIPACK | GADOBENATE DIMEGLUMINE | INJECTABLE;INTRAVENOUS | 52.9GM/100ML (529MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0270-5264 | MultiHance | gadobenate dimeglumine | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-5264 | MultiHance | gadobenate dimeglumine | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-5264 | MultiHance | gadobenate dimeglumine | BRACCO DIAGNOSTICS INC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81497 | SUPPL | 2025-03-07 |
| 81496 | SUPPL | 2025-03-07 |
| 81451 | SUPPL | 2025-03-06 |
| 79419 | SUPPL | 2024-08-16 |
| 79407 | SUPPL | 2024-08-16 |
| 79204 | SUPPL | 2024-07-24 |
| 79188 | SUPPL | 2024-07-24 |
| 77354 | SUPPL | 2024-01-30 |
| 77337 | SUPPL | 2024-01-29 |
| 56864 | SUPPL | 2018-12-20 |
| 56437 | SUPPL | 2018-11-14 |
| 56309 | SUPPL | 2018-11-06 |
| 53904 | SUPPL | 2018-05-01 |
| 53902 | SUPPL | 2018-05-01 |
| 53833 | SUPPL | 2018-04-27 |
| 53831 | SUPPL | 2018-04-27 |
| 51869 | SUPPL | 2018-01-26 |
| 51342 | SUPPL | 2018-01-19 |
| 49781 | SUPPL | 2017-09-19 |
| 49770 | SUPPL | 2017-09-18 |
| 36750 | SUPPL | 2013-08-09 |
| 5160 | SUPPL | 2013-08-01 |
| 36749 | SUPPL | 2012-07-10 |
| 27582 | SUPPL | 2012-07-09 |
| 5159 | SUPPL | 2011-10-03 |
| 15285 | SUPPL | 2011-02-24 |
| 5158 | SUPPL | 2011-02-18 |
| 15284 | SUPPL | 2007-09-06 |
| 5157 | SUPPL | 2007-09-06 |
| 44118 | ORIG | 2006-06-09 |
| 21615 | ORIG | 2005-04-17 |
| 36748 | ORIG | 2005-01-26 |
| 27581 | ORIG | 2004-12-02 |