Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018327
Company: CURIUM
Company: CURIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XENON XE 133 | XENON XE-133 | 10mCi/VIAL | GAS;INHALATION | Prescription | None | No | No |
XENON XE 133 | XENON XE-133 | 20mCi/VIAL | GAS;INHALATION | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
03/09/1982 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
03/09/2016 | SUPPL-5 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018327s005lbl.pdf | |
09/19/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/26/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/09/2016 | SUPPL-5 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018327s005lbl.pdf |