Application 201277
- Type
- NDA
- Sponsor
- BAYER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GADAVIST | GADOBUTROL | SOLUTION;INTRAVENOUS | 4.5354GM/7.5ML (604.72MG/ML) | Yes | Yes |
| 002 | GADAVIST | GADOBUTROL | SOLUTION;INTRAVENOUS | 6.0472GM/10ML (604.72MG/ML) | Yes | Yes |
| 003 | GADAVIST | GADOBUTROL | SOLUTION;INTRAVENOUS | 9.0708GM/15ML (604.72MG/ML) | Yes | Yes |
| 004 | GADAVIST | GADOBUTROL | SOLUTION;INTRAVENOUS | 18.1416GM/30ML (604.72MG/ML) | Yes | Yes |
| 005 | GADAVIST | GADOBUTROL | SOLUTION;INTRAVENOUS | 39.3068GM/65ML (604.72MG/ML) | Yes | Yes |
| 006 | GADAVIST | GADOBUTROL | SOLUTION;INTRAVENOUS | 1.20944GM/2ML (604.72MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
| 50419-325 | Gadavist | gadobutrol | Bayer HealthCare Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85094 | SUPPL | 2026-03-23 |
| 85095 | SUPPL | 2026-02-20 |
| 85050 | SUPPL | 2026-02-18 |
| 81494 | SUPPL | 2025-03-07 |
| 81453 | SUPPL | 2025-03-06 |
| 79196 | SUPPL | 2024-07-24 |
| 79180 | SUPPL | 2024-07-24 |
| 77345 | SUPPL | 2024-01-29 |
| 77338 | SUPPL | 2024-01-29 |
| 71104 | SUPPL | 2022-05-20 |
| 71103 | SUPPL | 2022-05-20 |
| 64182 | SUPPL | 2020-08-03 |
| 64181 | SUPPL | 2020-08-03 |
| 64152 | SUPPL | 2020-07-31 |
| 59332 | SUPPL | 2019-07-15 |
| 59325 | SUPPL | 2019-07-12 |
| 59324 | SUPPL | 2019-07-12 |
| 56456 | SUPPL | 2018-11-15 |
| 56305 | SUPPL | 2018-11-06 |
| 55038 | SUPPL | 2018-07-30 |
| 55023 | SUPPL | 2018-07-27 |
| 55022 | SUPPL | 2018-07-27 |
| 53909 | SUPPL | 2018-05-01 |
| 53854 | SUPPL | 2018-04-27 |
| 18998 | SUPPL | 2016-05-05 |
| 9874 | SUPPL | 2016-04-28 |
| 18997 | SUPPL | 2015-09-21 |
| 9873 | SUPPL | 2015-08-03 |
| 40057 | SUPPL | 2015-01-05 |
| 9872 | SUPPL | 2014-12-31 |
| 9871 | SUPPL | 2014-06-12 |
| 40056 | SUPPL | 2013-10-21 |
| 32090 | SUPPL | 2013-10-18 |
| 9870 | SUPPL | 2012-03-26 |
| 44833 | ORIG | 2011-04-11 |
| 22848 | ORIG | 2011-04-11 |
| 32089 | ORIG | 2011-03-16 |
| 40055 | ORIG | 2011-03-15 |
| 66905 | ORIG | 1900-01-01 |
| 66904 | ORIG | 1900-01-01 |
| 66903 | ORIG | 1900-01-01 |
| 54108 | ORIG | 1900-01-01 |
| 54107 | ORIG | 1900-01-01 |
| 51135 | SUPPL | 1900-01-01 |
| 51134 | SUPPL | 1900-01-01 |
| 51133 | SUPPL | 1900-01-01 |