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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020862
Company: SANOFI

Products on NDA 020862

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HECTOROL	DOXERCALCIFEROL	2.5MCG	CAPSULE;ORAL	Discontinued	None	Yes	No
HECTOROL	DOXERCALCIFEROL	0.5MCG	CAPSULE;ORAL	Discontinued	None	Yes	No
HECTOROL	DOXERCALCIFEROL	1MCG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020862

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2025	SUPPL-33	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020862s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020862Orig1s033ltr.pdf
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.

Labels for NDA 020862

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2025	SUPPL-33	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020862s033lbl.pdf
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

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