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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020313
Company: MYLAN IRELAND LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIACALCIN CALCITONIN SALMON 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED;NASAL Discontinued None Yes No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
08/17/1995 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2017 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020313s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020313Orig1s036ltr.pdf
02/27/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
03/11/2014 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020313s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020313Orig1s034ltr.pdf
04/18/2012 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020313s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020313s033ltr.pdf
10/30/2009 SUPPL-29 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020313s029lbl.pdf
08/22/2003 SUPPL-23 Manufacturing (CMC)-Control Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20313scs023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020313_S023_MIACALCIN_AP.pdf
01/06/2006 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020313s021ltr.pdf
05/10/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
11/02/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
07/14/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
07/23/1999 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
01/13/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
12/17/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
08/14/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
01/12/1998 SUPPL-10 Labeling

Label is not available on this site.
09/15/1997 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
08/01/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
04/24/1997 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
03/27/1997 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
12/24/1998 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/07/1997 SUPPL-3 Labeling

Label is not available on this site.
10/22/1996 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/12/2017 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020313s036lbl.pdf
03/11/2014 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020313s034lbl.pdf
04/18/2012 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020313s033lbl.pdf
10/30/2009 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020313s029lbl.pdf
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