Application 017707
- Type
- NDA
- Sponsor
- GE HEALTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MPI INDIUM DTPA IN 111 | INDIUM IN-111 PENTETATE DISODIUM | INJECTABLE;INTRATHECAL | 1mCi/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17156-251 | Indium DTPA In 111 | Indium In-111 Pentetate Disodium | Medi-Physics, Inc. dba GE Healthcare | NDA | Current |
| 17156-251 | Indium DTPA In 111 | Indium In-111 Pentetate Disodium | Medi-Physics, Inc. dba GE Healthcare | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 13886 | SUPPL | 2004-09-27 |