Application 022454
- Type
- NDA
- Sponsor
- GE HLTHCARE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DATSCAN | IOFLUPANE I-123 | SOLUTION;INTRAVENOUS | 5mCi/2.5ML (2mCi/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17156-210 | DaTscan | Ioflupane I-123 | Medi-Physics Inc. dba GE Healthcare. | NDA | Current |
| 17156-210 | DaTscan | Ioflupane I-123 | Medi-Physics Inc. dba GE Healthcare. | NDA | Current |
| 17156-210 | DaTscan | Ioflupane I-123 | Medi-Physics Inc. dba GE Healthcare. | NDA | Current |
| 17156-210 | DaTscan | Ioflupane I-123 | Medi-Physics Inc. dba GE Healthcare. | NDA | Current |
| 17156-210 | DaTscan | Ioflupane I-123 | Medi-Physics Inc. dba GE Healthcare. | NDA | Current |
| 17156-210 | DaTscan | Ioflupane I-123 | Medi-Physics Inc. dba GE Healthcare. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85706 | SUPPL | 2026-04-17 |
| 85700 | SUPPL | 2026-04-16 |
| 72772 | SUPPL | 2022-12-05 |
| 72759 | SUPPL | 2022-12-01 |
| 72548 | SUPPL | 2022-11-02 |
| 72534 | SUPPL | 2022-11-02 |
| 62346 | SUPPL | 2020-03-26 |
| 62343 | SUPPL | 2020-03-26 |
| 38722 | SUPPL | 2015-09-11 |
| 29739 | SUPPL | 2015-09-11 |
| 23083 | SUPPL | 2015-09-11 |
| 38721 | ORIG | 2015-07-28 |
| 44756 | ORIG | 2011-02-17 |
| 22024 | ORIG | 2011-02-16 |
| 29738 | ORIG | 2011-01-20 |