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Application 022290
- Type
- NDA
- Sponsor
- GE HEALTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ADREVIEW | IOBENGUANE SULFATE I-123 | SOLUTION;INTRAVENOUS | 10mCi/5ML (2mCi/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 17156-235 | AdreView | Iobenguane I-123 | Medi-Physics Inc. | NDA | Current |
| 17156-235 | AdreView | Iobenguane I-123 | Medi-Physics Inc. | NDA | Current |
| 17156-235 | AdreView | Iobenguane I-123 | Medi-Physics Inc. | NDA | Current |
| 17156-235 | AdreView | Iobenguane I-123 | Medi-Physics Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 62083 | SUPPL | 2020-03-09 |
| 62069 | SUPPL | 2020-03-06 |
| 38518 | SUPPL | 2013-03-26 |
| 7185 | SUPPL | 2013-03-22 |
| 24276 | ORIG | 2008-10-23 |
| 21983 | ORIG | 2008-10-23 |
| 7184 | ORIG | 2008-09-23 |
| 38517 | ORIG | 2008-09-19 |