Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017550
Company: GEN ELECTRIC
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. |