Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019862
Company: GE HEALTHCARE
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INDICLOR | INDIUM IN-111 CHLORIDE | 2mCi/0.2ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/29/1992 | 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 |
---|---|---|---|---|---|
06/20/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/09/2003 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
04/24/2003 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/in111med042403LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/in111med042403L.pdf | |
02/19/2002 | SUPPL-6 | Labeling |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111med021902LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/in111med021902L.htm | |
10/28/1996 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/24/2003 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/in111med042403LB.pdf | |
02/19/2002 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111med021902LB.pdf |