Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017256
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 | 1.3-1.7 CI/AMP | INJECTABLE;INJECTION | Discontinued | None | No | No |
XENON XE 133 | XENON XE-133 | 1 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 |
---|---|---|---|---|---|---|---|
11/09/1976 | 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 |
---|---|---|---|---|---|
09/17/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
09/17/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
02/29/1980 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
05/01/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |