Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017808
Company: MYLAN IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIACALCIN CALCITONIN SALMON 100 IU/ML INJECTABLE;INJECTION Discontinued None Yes No
MIACALCIN CALCITONIN SALMON 200 IU/ML INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/03/1986 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
09/11/2017 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017808s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017808Orig1s037ltr.pdf
02/02/2015 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017808s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017808Orig1s036ltr.pdf
03/11/2014 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017808s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017808Orig1s035ltr.pdf
04/18/2012 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017808s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017808s034ltr.pdf
02/19/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/30/2009 SUPPL-30 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017808s030lbl.pdf
06/03/2003 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17808slr024ltr.pdf
02/12/2002 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/02/2001 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/23/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/13/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/24/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/14/1997 SUPPL-14 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/017808a_s014.pdf
08/01/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/14/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/09/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1992 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1992 SUPPL-7 Labeling

Label is not available on this site.

06/10/1992 SUPPL-6 Labeling

Label is not available on this site.

07/22/1994 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/26/1993 SUPPL-3 Labeling

Label is not available on this site.

10/03/1991 SUPPL-2 Labeling

Label is not available on this site.

03/29/1991 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/11/2017 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017808s037lbl.pdf
02/02/2015 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017808s036lbl.pdf
03/11/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017808s035lbl.pdf
04/18/2012 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017808s034lbl.pdf
10/30/2009 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017808s030lbl.pdf

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