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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022150
Company: TAKEDA PHARMS USA
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/19/2024 SUPPL-16 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022150s016lbl.pdf
04/28/2022 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022150Orig1s014lbl.pdf
04/28/2022 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022150Orig1s014lbl.pdf
04/16/2020 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022150s012s013lbl.pdf
04/16/2020 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022150s012s013lbl.pdf
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
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