Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017707
Company: GE HEALTHCARE
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MPI INDIUM DTPA IN 111 | INDIUM IN-111 PENTETATE DISODIUM | 1mCi/ML | INJECTABLE;INTRATHECAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/18/1982 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/2004 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17707s010ltr.pdf |
| 04/30/2002 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/28/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/27/1984 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |