Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018536
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.

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