Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075746
Company: AM REGENT
Company: AM REGENT
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 |
CALCITRIOL | CALCITRIOL | 0.002MG/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 |
---|---|---|---|---|---|---|---|
09/26/2003 | 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 |
---|---|---|---|---|---|
07/06/2008 | SUPPL-3 |
Label is not available on this site. |