Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020862
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 201518 ANDA REPOSITORY
DOXERCALCIFEROL DOXERCALCIFEROL 2.5MCG CAPSULE;ORAL Prescription No AB 091433 HIKMA
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 201518 ANDA REPOSITORY
DOXERCALCIFEROL DOXERCALCIFEROL 0.5MCG CAPSULE;ORAL Prescription No AB 091433 HIKMA
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 201518 ANDA REPOSITORY
DOXERCALCIFEROL DOXERCALCIFEROL 1MCG CAPSULE;ORAL Prescription No AB 091433 HIKMA
HECTOROL DOXERCALCIFEROL 1MCG CAPSULE;ORAL Prescription Yes AB 020862 SANOFI

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