Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021027
Company: SANOFI
Company: SANOFI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HECTOROL | DOXERCALCIFEROL | 4MCG/2ML (2MCG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| HECTOROL | DOXERCALCIFEROL | 2MCG/ML (2MCG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/28/2022 | SUPPL-38 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021027Orig1s038lbl.pdf | |
| 11/21/2018 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020862s031,021027s034lbl.pdf | |
| 06/01/2016 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021027s026lbl.pdf | |
| 12/05/2008 | SUPPL-15 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021027s015lbl.pdf | |
| 07/20/2006 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.pdf | |
| 06/22/2005 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021027s012lbl.pdf | |
| 04/06/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21027lbl.pdf |