Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207141
Company: LINDE GAS EQUIP

Products on ANDA 207141

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOXIVENT	NITRIC OXIDE	100PPM	GAS;INHALATION	Prescription	None	No	Yes
NOXIVENT	NITRIC OXIDE	800PPM	GAS;INHALATION	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207141

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/02/2018	ORIG-1	Approval		STANDARD	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207141Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/207141Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207141

NOXIVENT

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	LINDE GAS EQUIP
ULSPIRA	NITRIC OXIDE	800PPM	GAS;INHALATION	Prescription	No	AA	203144	AIRGAS THERAP