Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205982
Company: EUGIA PHARMA
Company: EUGIA PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PARICALCITOL | PARICALCITOL | 0.002MG/ML (0.002MG/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| PARICALCITOL | PARICALCITOL | 0.005MG/ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| PARICALCITOL | PARICALCITOL | 0.01MG/2ML (0.005MG/ML) | SOLUTION;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 10/09/2018 | ORIG-1 | Approval | 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 |
|---|---|---|---|---|---|
| 07/24/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |