Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017653
Company: GE HEALTHCARE
Company: GE HEALTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CINTICHEM TECHNETIUM 99M HEDSPA | 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 |
|---|---|---|---|---|---|---|---|
| 11/18/1976 | 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 |
|---|---|---|---|---|---|
| 02/02/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/10/1979 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1977 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/08/1977 | SUPPL-1 | Labeling |
Label is not available on this site. |