Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207141
Company: PRAXAIR DISTRIBUTION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOXIVENT NITRIC OXIDE 100PPM GAS;INHALATION Prescription None No No
NOXIVENT NITRIC OXIDE 800PPM GAS;INHALATION Prescription AA No No
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)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207141Orig1s000Ltr.pdf

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 PRAXAIR DISTRIBUTION

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