Application 203684
- Type
- NDA
- Sponsor
- BRACCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LUMASON | SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES | FOR SUSPENSION;INTRAVENOUS | 60.7MG/25MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0270-7097 | Lumason | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | Lumason | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | Lumason | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | Lumason | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | Lumason | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7097 | Lumason | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 0270-7099 | LumaSon | SULFUR HEXAFLUORIDE | BRACCO DIAGNOSTICS INC | NDA | Current |
| 68155-099 | LumaSon | SULFUR HEXAFLUORIDE | Bracco Suisse SA | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67032 | SUPPL | 2021-04-13 |
| 67018 | SUPPL | 2021-04-12 |
| 65492 | SUPPL | 2020-12-03 |
| 65496 | SUPPL | 2020-12-02 |
| 60845 | SUPPL | 2019-11-15 |
| 60832 | SUPPL | 2019-11-14 |
| 46527 | SUPPL | 2016-12-23 |
| 46514 | SUPPL | 2016-12-22 |
| 40321 | SUPPL | 2016-04-05 |
| 32459 | SUPPL | 2016-04-04 |
| 43442 | ORIG | 2014-12-05 |
| 40320 | ORIG | 2014-12-05 |
| 24445 | ORIG | 2014-12-05 |
| 32458 | ORIG | 2014-10-15 |
| 63276 | SUPPL | 1900-01-01 |
| 63275 | SUPPL | 1900-01-01 |
| 51669 | ORIG | 1900-01-01 |
| 51598 | ORIG | 1900-01-01 |
| 51597 | ORIG | 1900-01-01 |
| 51596 | ORIG | 1900-01-01 |