Application 020899
- Type
- NDA
- Sponsor
- GE HEALTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OPTISON | ALBUMIN HUMAN | INJECTABLE;INJECTION | 10MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0407-2707 | Optison | Human Albumin Microspheres and Perflutren | GE Healthcare Inc. | NDA | Current |
| 0407-2707 | Optison | Human Albumin Microspheres and Perflutren | GE Healthcare Inc. | NDA | Current |
| 0407-2707 | Optison | Human Albumin Microspheres and Perflutren | GE Healthcare Inc. | NDA | Current |
| 0407-2707 | Optison | Human Albumin Microspheres and Perflutren | GE Healthcare Inc. | NDA | Current |
| 0407-2707 | Optison | Human Albumin Microspheres and Perflutren | GE Healthcare Inc. | NDA | Current |
| 0407-2707 | Optison | Human Albumin Microspheres and Perflutren | GE Healthcare Inc. | NDA | Current |
| 0407-2707 | Optison | Human Albumin Microspheres and Perflutren | GE Healthcare Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82191 | SUPPL | 2025-05-15 |
| 82254 | SUPPL | 2025-05-09 |
| 68668 | SUPPL | 2021-09-20 |
| 68654 | SUPPL | 2021-09-20 |
| 68533 | SUPPL | 2021-09-03 |
| 45347 | SUPPL | 2016-09-20 |
| 45346 | SUPPL | 2016-09-20 |
| 45314 | SUPPL | 2016-09-16 |
| 45313 | SUPPL | 2016-09-16 |
| 35600 | SUPPL | 2012-08-20 |
| 26144 | SUPPL | 2012-08-20 |
| 23609 | ORIG | 2008-07-11 |
| 35599 | SUPPL | 2008-06-12 |
| 3691 | SUPPL | 2008-06-09 |
| 3690 | SUPPL | 2007-11-19 |
| 13698 | SUPPL | 2007-10-04 |
| 3689 | SUPPL | 2002-05-10 |