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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021406
Company: UPSHER SMITH LABS

Products on NDA 021406

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FORTICAL	CALCITONIN SALMON RECOMBINANT	200 IU/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021406

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

Labels for NDA 021406

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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