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. |
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11/18/1983 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |