Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091433
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXERCALCIFEROL | DOXERCALCIFEROL | 0.5MCG | CAPSULE;ORAL | Discontinued | None | No | No |
| DOXERCALCIFEROL | DOXERCALCIFEROL | 1MCG | CAPSULE;ORAL | Discontinued | None | No | No |
| DOXERCALCIFEROL | DOXERCALCIFEROL | 2.5MCG | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/2014 | ORIG-2 | Approval |
Label is not available on this site. |
||||
| 09/23/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091433s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/13/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |