Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021027
Company: SANOFI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HECTOROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
HECTOROL DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE;INJECTION Prescription AP 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
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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-Package Insert, Labeling-Container/Carton Labels

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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

HECTOROL

INJECTABLE;INJECTION; 4MCG/2ML (2MCG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 203929 AKORN INC
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 208974 AMNEAL
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 208975 AMNEAL
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 210452 GLAND PHARMA LTD
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 091101 HIKMA PHARMS
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription Yes AP 208614 HOSPIRA INC
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 210801 LUPIN LTD
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 091333 SANDOZ INC
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 200926 SANDOZ INC
DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 203875 SUN PHARM
HECTOROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE;INJECTION Prescription Yes AP 021027 SANOFI

INJECTABLE;INJECTION; 2MCG/ML (2MCG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXERCALCIFEROL DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 203929 AKORN INC
DOXERCALCIFEROL DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 208974 AMNEAL
DOXERCALCIFEROL DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE;INJECTION Prescription No AP 203875 SUN PHARM
HECTOROL DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE;INJECTION Prescription Yes AP 021027 SANOFI

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