Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021406
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FORTICAL CALCITONIN SALMON RECOMBINANT 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SPRAY, METERED;NASAL Discontinued None No No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
08/12/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021406lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021406ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021406s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/16/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/24/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/09/2014 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021406s017s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021406Orig1s017,s022ltr.pdf
07/09/2014 SUPPL-17 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021406Orig1s017,s022ltr.pdf
08/12/2011 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021406s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021406s016ltr.pdf
06/22/2009 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021406s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021406s008ltr.pdf
02/02/2007 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021406s007ltr.pdf
04/27/2006 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021406s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021406s003LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/09/2014 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021406s017s022lbl.pdf
08/12/2011 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021406s016lbl.pdf
06/22/2009 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021406s008lbl.pdf
04/27/2006 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021406s003lbl.pdf
08/12/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021406lbl.pdf

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