Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019841
Company: CURIUM
Company: CURIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INDIUM IN 111 CHLORIDE | INDIUM IN-111 CHLORIDE | 5mCi/0.5ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
09/27/1994 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/26/2017 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/19/2002 | SUPPL-3 | Labeling |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111mal021902LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/in111mal021902L.htm | |
07/03/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
10/28/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/19/2002 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/in111mal021902LB.pdf |