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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020845
Company: MALLINCKRODT IRELAND

Products on NDA 020845

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INOMAX	NITRIC OXIDE	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS;INHALATION	Discontinued	None	Yes	No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
INOMAX	NITRIC OXIDE	4880PPM	GAS;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020845

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-21	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020845Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020845Orig1s021ltr.pdf
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.

Labels for NDA 020845

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-21	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020845Orig1s021lbl.pdf
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

Therapeutic Equivalents for NDA 020845

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 IRELAND
NOXIVENT	NITRIC OXIDE	800PPM	GAS;INHALATION	Prescription	No	AA	207141	VERO BIOTECH INC
ULSPIRA	NITRIC OXIDE	800PPM	GAS;INHALATION	Prescription	No	AA	203144	AIRGAS THERAP

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