Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200926
Company: CAPLIN
Company: CAPLIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXERCALCIFEROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DOXERCALCIFEROL | DOXERCALCIFEROL | 2MCG/ML (2MCG/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 |
|---|---|---|---|---|---|---|---|
| 02/04/2014 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200926Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/22/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/13/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/04/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |