Drugs@FDA: FDA Approved Drug Products

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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INOMAX NITRIC OXIDE 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** GAS;INHALATION Discontinued None Yes No
INOMAX NITRIC OXIDE 800PPM GAS;INHALATION Prescription AA 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
12/23/1999 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20845lbl.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20845ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20845_INOmax.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020845s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020845Orig1s020ltr.pdf
04/05/2016 SUPPL-18 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020845Orig1s018ltr.pdf
10/09/2015 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020845Orig1s016,s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020845Orig1s017.pdf
10/09/2015 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020845Orig1s016,s017ltr.pdf
02/28/2014 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/04/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020845s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020845Orig1s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020845Orig1s014.pdf
12/21/2010 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020845s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020845s011ltr.pdf
08/26/2009 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020845s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020845s009ltr.pdf
12/04/2007 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020845s004ltr.pdf
06/15/2004 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20845slr002ltr.pdf
05/21/2001 SUPPL-1 Labeling

Label is not available on this site.

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

INOMAX

GAS;INHALATION; 800PPM
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INOMAX NITRIC OXIDE 800PPM GAS;INHALATION Prescription Yes AA 020845 MALLINCKRODT HOSP
NOXIVENT NITRIC OXIDE 800PPM GAS;INHALATION Prescription No AA 207141 PRAXAIR DISTRIBUTION

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