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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021027
Company: SANOFI

Products on NDA 021027

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021027

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21027_Hectorol.html

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021027Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021027Orig1s038ltr.pdf
11/21/2018	SUPPL-34	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
12/15/2015	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
09/11/2014	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
07/31/2014	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
12/24/2013	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
09/23/2013	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
06/01/2016	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021027s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021027Orig1s026ltr.pdf
12/15/2010	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/05/2008	SUPPL-15	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021027s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021027s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021027Orig1s015.pdf
07/20/2006	SUPPL-13	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/2006/021027s013,020862s019ltr.pdf
06/22/2005	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021027s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021027s012ltr.pdf
11/26/2003	SUPPL-7	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21027scm007ltr.pdf
11/19/2002	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/24/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/03/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/26/2001	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021027

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

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