Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016224
Company: BRACCO
Company: BRACCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROBENGATOPE | ROSE BENGAL SODIUM I-131 | 0.5mCi/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ROBENGATOPE | ROSE BENGAL SODIUM I-131 | 1mCi/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ROBENGATOPE | ROSE BENGAL SODIUM I-131 | 2mCi/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/23/1971 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/13/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/11/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/1976 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1976 | SUPPL-4 | Labeling |
Label is not available on this site. |