Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017687
Company: GE HEALTHCARE
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XENON XE 133 | XENON XE-133 | 10mCi/VIAL | GAS;INHALATION | Discontinued | None | No | No |
XENON XE 133 | XENON XE-133 | 20mCi/VIAL | GAS;INHALATION | Discontinued | None | No | No |
XENON XE 133-V.S.S. | XENON XE-133 | 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 |
---|---|---|---|---|---|---|---|
11/16/1976 | 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 |
---|---|---|---|---|---|
05/22/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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11/07/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
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02/27/1981 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |