Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022150
Company: SHIRE ORPHAN THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FIRAZYR ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription AP 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
08/25/2011 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022150s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022150s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022150_firazyr_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2016 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/24/2015 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022150Orig1s007ltr.pdf
08/10/2015 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022150Orig1s006ltr.pdf
08/30/2013 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022150s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022150Orig1s004ltr.pdf
01/28/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/28/2012 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/24/2015 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s007lbl.pdf
08/10/2015 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s006lbl.pdf
08/30/2013 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022150s004lbl.pdf
08/25/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022150s000lbl.pdf

FIRAZYR

INJECTABLE;SUBCUTANEOUS; EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FIRAZYR ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AP 022150 SHIRE ORPHAN THERAP
ICATIBANT ACETATE ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 210118 TEVA PHARMS USA

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