Drugs@FDA: FDA-Approved Drugs
Company: SANOFI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HECTOROL | DOXERCALCIFEROL | 2.5MCG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
HECTOROL | DOXERCALCIFEROL | 0.5MCG | CAPSULE;ORAL | Prescription | AB | Yes | No |
HECTOROL | DOXERCALCIFEROL | 1MCG | CAPSULE;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
06/09/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20862lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20862ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020862_Hectorol.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/02/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/21/2018 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020862s031,021027s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020862Orig1s031,021027Orig1s034ltr.pdf | |
02/11/2011 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020862s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020862s030ltr.pdf | |
07/13/2009 | SUPPL-24 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020862s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020862s024ltr.pdf | |
07/10/2008 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020862s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020862s023ltr.pdf | |
07/20/2006 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020862s019ltr.pdf | |
06/24/2005 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020862s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020862s018ltr.pdf | |
12/17/2004 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20862s016ltr.pdf |
11/19/2002 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/24/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/17/2002 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
06/03/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/23/2004 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20862se1-006_hectorol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20862se1-006ltr.pdf | |
06/26/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/2001 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
06/25/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/21/2018 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020862s031,021027s034lbl.pdf | |
02/11/2011 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020862s030lbl.pdf | |
07/13/2009 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020862s024lbl.pdf | |
07/13/2009 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020862s024lbl.pdf | |
07/10/2008 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020862s023lbl.pdf | |
07/10/2008 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020862s023lbl.pdf | |
07/20/2006 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.pdf | |
06/24/2005 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020862s018lbl.pdf | |
04/23/2004 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20862se1-006_hectorol_lbl.pdf | |
06/09/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20862lbl.pdf |
HECTOROL
CAPSULE;ORAL; 2.5MCG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 2.5MCG | CAPSULE;ORAL | Prescription | No | AB | 205360 | AVET |
DOXERCALCIFEROL | DOXERCALCIFEROL | 2.5MCG | CAPSULE;ORAL | Prescription | No | AB | 201518 | RISING |
HECTOROL | DOXERCALCIFEROL | 2.5MCG | CAPSULE;ORAL | Prescription | Yes | AB | 020862 | SANOFI |
CAPSULE;ORAL; 0.5MCG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 0.5MCG | CAPSULE;ORAL | Prescription | No | AB | 205360 | AVET |
DOXERCALCIFEROL | DOXERCALCIFEROL | 0.5MCG | CAPSULE;ORAL | Prescription | No | AB | 201518 | RISING |
HECTOROL | DOXERCALCIFEROL | 0.5MCG | CAPSULE;ORAL | Prescription | Yes | AB | 020862 | SANOFI |
CAPSULE;ORAL; 1MCG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | DOXERCALCIFEROL | 1MCG | CAPSULE;ORAL | Prescription | No | AB | 205360 | AVET |
DOXERCALCIFEROL | DOXERCALCIFEROL | 1MCG | CAPSULE;ORAL | Prescription | No | AB | 201518 | RISING |
HECTOROL | DOXERCALCIFEROL | 1MCG | CAPSULE;ORAL | Prescription | Yes | AB | 020862 | SANOFI |