Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020845
Company: MALLINCKRODT HOSP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INOMAX NITRIC OXIDE 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GAS;INHALATION Discontinued None Yes No
INOMAX NITRIC OXIDE 800PPM GAS;INHALATION Prescription AA Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/13/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020845s020lbl.pdf
10/09/2015 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf
10/09/2015 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf
03/04/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020845s014lbl.pdf
12/21/2010 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020845s011lbl.pdf
08/26/2009 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020845s009lbl.pdf
12/23/1999 ORIG-1 Approval https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20845lbl.htm

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