Skip to content
Application 214271
- Type
- ANDA
- Sponsor
- JIANGSU PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IODIXANOL | IODIXANOL | INJECTABLE;INJECTION | 55% | No | No |
| 002 | IODIXANOL | IODIXANOL | INJECTABLE;INJECTION | 65.2% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65219-381 | Iodixanol | Iodixanol | FRESENIUS KABI USA, LLC | ANDA | Current |
| 65219-381 | Iodixanol | Iodixanol | FRESENIUS KABI USA, LLC | ANDA | Current |
| 65219-383 | Iodixanol | Iodixanol | FRESENIUS KABI USA, LLC | ANDA | Current |
| 65219-383 | Iodixanol | Iodixanol | FRESENIUS KABI USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71882 | ORIG | 2022-08-25 |