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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

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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020862s024lbl.pdf
07/13/2009 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020862s024lbl.pdf
07/10/2008 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020862s023lbl.pdf
07/10/2008 SUPPL-23 Labeling-Container/Carton Labels 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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