Application 011525
- Type
- NDA
- Sponsor
- AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IC-GREEN | INDOCYANINE GREEN | INJECTABLE;INJECTION | 25MG/VIAL | Yes | Yes |
| 002 | IC-GREEN | INDOCYANINE GREEN | INJECTABLE;INJECTION | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 003 | IC-GREEN | INDOCYANINE GREEN | INJECTABLE;INJECTION | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 004 | IC-GREEN | INDOCYANINE GREEN | INJECTABLE;INJECTION | 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17478-701 | IC-Green | indocyanine green | Akorn | NDA | Current |
| 17478-701 | IC-Green | indocyanine green | Akorn, Inc. | NDA | Current |
| 17478-701 | IC-Green | indocyanine green | Akorn | NDA | Current |
| 17478-701 | IC-Green | indocyanine green | Akorn, Inc. | NDA | Current |
| 17478-701 | IC-Green | indocyanine green | Akorn | NDA | Current |
| 17478-701 | IC-Green | indocyanine green | Akorn, Inc. | NDA | Current |
| 66259-701 | IC-Green | Indocyanine Green | Novadaq Technologies Inc. | NDA | Current |
| 69450-701 | IC-GREEN | Indocyanine Green | Novadaq Technologies, Inc. | NDA | Current |
| 75874-701 | IC-Green | Indocyanine Green | Novadaq Technologies Inc. | NDA | Current |