Application 021870
- Type
- NDA
- Sponsor
- FEINSTEIN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-200mCi/ML | Yes | No |
| 002 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-400mCi/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13267-123 | Fludeoxyglucose F18 | Fludeoxyglucose F18 | THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | NDA | Current |
| 13267-234 | Fludeoxyglucose | Fludeoxyglucose F18 | THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | NDA | Current |
| 13267-234 | Fludeoxyglucose | Fludeoxyglucose F18 | THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | NDA | Current |
| 13267-234 | Fludeoxyglucose | Fludeoxyglucose F18 | THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76610 | SUPPL | 2023-11-17 |
| 76561 | SUPPL | 2023-11-14 |
| 59228 | SUPPL | 2019-07-03 |
| 59199 | SUPPL | 2019-06-28 |
| 59194 | SUPPL | 2019-06-28 |
| 16489 | SUPPL | 2012-01-23 |
| 28746 | SUPPL | 2012-01-20 |
| 28745 | SUPPL | 2011-01-07 |
| 16488 | SUPPL | 2011-01-06 |
| 37795 | SUPPL | 2010-08-20 |
| 6346 | SUPPL | 2010-08-20 |
| 21849 | ORIG | 2007-07-18 |
| 37794 | ORIG | 2005-08-23 |
| 6345 | ORIG | 2005-08-23 |