Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017667
Company: GE HEALTHCARE
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MPI STANNOUS DIPHOSPHONATE | TECHNETIUM TC-99M ETIDRONATE KIT | N/A | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 04/01/1977 | 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-4 | Labeling |
Label is not available on this site. |
||
| 08/03/1979 | SUPPL-3 | Labeling |
Label is not available on this site. |