Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017550
Company: GEN ELECTRIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XENON XE 133 XENON XE-133 5-100 CI/CYLINDER GAS;INHALATION Discontinued None No No
XENON XE 133 XENON XE-133 0.25-5 CI/AMP 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
03/24/1976 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
07/31/1986 SUPPL-6 Labeling

Label is not available on this site.

05/30/1986 SUPPL-5 Labeling

Label is not available on this site.

12/12/1979 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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