Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076206
Company: ROCKWELL MEDCL
Company: ROCKWELL MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCITRIOL | CALCITRIOL | 0.001MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/17/2003 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/17/2014 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/14/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 02/23/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |