Skip to contentApplication 203155
- Type
- NDA
- Sponsor
- MCPRF
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CHOLINE C-11 | CHOLINE C-11 | INJECTABLE;INTRAVENOUS | 4-33.1mCi/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52670-556 | Choline C 11 | Choline C-11 | Mayo Clinic | NDA | Current |
| 52670-556 | Choline C 11 | Choline C-11 | Mayo Clinic | NDA | Current |
| 52670-556 | Choline C 11 | Choline C-11 | Mayo Clinic | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79575 | SUPPL | 2024-09-10 |
| 79569 | SUPPL | 2024-09-10 |
| 44877 | ORIG | 2012-09-18 |
| 43422 | ORIG | 2012-09-17 |
| 19435 | ORIG | 2012-09-14 |
| 10172 | ORIG | 2012-09-14 |