Application 204781
- Type
- NDA
- Sponsor
- GUERBET
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOTAREM | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 37.69GM/100ML (376.9MG/ML) | Yes | Yes |
| 002 | DOTAREM | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 3.769GM/10ML (376.9MG/ML) | Yes | Yes |
| 003 | DOTAREM | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 5.6535GM/15ML (376.9MG/ML) | Yes | Yes |
| 004 | DOTAREM | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 7.538GM/20ML (376.9MG/ML) | Yes | Yes |
| 005 | DOTAREM | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 1.8845GM/5ML (376.9MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2000 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-2001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-3001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-3001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-3001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-3001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
| 67684-3001 | DOTAREM | gadoterate meglumine | Guerbet LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81489 | SUPPL | 2025-03-07 |
| 81488 | SUPPL | 2025-03-07 |
| 81455 | SUPPL | 2025-03-06 |
| 81454 | SUPPL | 2025-03-06 |
| 79889 | SUPPL | 2024-10-15 |
| 79415 | SUPPL | 2024-08-16 |
| 79197 | SUPPL | 2024-07-24 |
| 79182 | SUPPL | 2024-07-24 |
| 77347 | SUPPL | 2024-01-29 |
| 77340 | SUPPL | 2024-01-29 |
| 59452 | SUPPL | 2019-07-25 |
| 59451 | SUPPL | 2019-07-25 |
| 59436 | SUPPL | 2019-07-24 |
| 56470 | SUPPL | 2018-11-15 |
| 56300 | SUPPL | 2018-11-06 |
| 56294 | SUPPL | 2018-11-06 |
| 53911 | SUPPL | 2018-05-01 |
| 53835 | SUPPL | 2018-04-27 |
| 49792 | SUPPL | 2017-09-19 |
| 49744 | SUPPL | 2017-09-15 |
| 49559 | SUPPL | 2017-08-28 |
| 49558 | SUPPL | 2017-08-28 |
| 44910 | ORIG | 2013-05-10 |
| 43478 | ORIG | 2013-05-10 |
| 19598 | ORIG | 2013-03-26 |
| 32589 | ORIG | 2013-03-22 |
| 63045 | SUPPL | 1900-01-01 |
| 63044 | SUPPL | 1900-01-01 |
| 63043 | SUPPL | 1900-01-01 |
| 51146 | ORIG | 1900-01-01 |
| 51145 | ORIG | 1900-01-01 |
| 51144 | ORIG | 1900-01-01 |