Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019981
Company: CURIUM
Company: CURIUM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ULTRATAG | TECHNETIUM TC-99M RED BLOOD CELL KIT | N/A | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/10/1991 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 09/09/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/30/1993 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/25/1992 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |