Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019350
Company: ABRAXIS PHARM
Company: ABRAXIS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CUPRIC SULFATE | CUPRIC SULFATE | EQ 0.4MG COPPER/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/05/1987 | 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 |
|---|---|---|---|---|---|
| 06/09/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/15/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |