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Application 022066
- Type
- NDA
- Sponsor
- GE HEALTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OMNISCAN | GADODIAMIDE | INJECTABLE;INJECTION | 14.35GM/50ML (287MG/ML) | No | No |
| 002 | OMNISCAN | GADODIAMIDE | INJECTABLE;INJECTION | 28.7GM/100ML (287MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0407-0690 | OMNISCAN | gadodiamide | GE Healthcare Inc. | NDA | Current |
| 0407-0690 | OMNISCAN | gadodiamide | GE Healthcare Inc. | NDA | Current |