Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018536
Company: MALLINCKRODT
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XENON XE 127 | XENON XE-127 | 5mCi/VIAL | GAS;INHALATION | Discontinued | None | No | No |
| XENON XE 127 | XENON XE-127 | 10mCi/VIAL | GAS;INHALATION | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 10/01/1982 | 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 |
|---|---|---|---|---|---|
| 06/21/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1983 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |