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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020845

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INOMAX (NITRIC OXIDE)
800PPM
Marketing Status: Prescription
Active Ingredient: NITRIC OXIDE
Proprietary Name: INOMAX
Dosage Form; Route of Administration: GAS; INHALATION
Strength: 800PPM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N020845
Product Number: 003
Approval Date: Dec 23, 1999
Applicant Holder Full Name: MALLINCKRODT HOSP PRODUCTS IP LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
INOMAX (NITRIC OXIDE)
4880PPM
Marketing Status: Prescription
Active Ingredient: NITRIC OXIDE
Proprietary Name: INOMAX
Dosage Form; Route of Administration: GAS; INHALATION
Strength: 4880PPM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020845
Product Number: 004
Approval Date: Jan 17, 2023
Applicant Holder Full Name: MALLINCKRODT HOSP PRODUCTS IP LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
INOMAX (NITRIC OXIDE)
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NITRIC OXIDE
Proprietary Name: INOMAX
Dosage Form; Route of Administration: GAS; INHALATION
Strength: 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020845
Product Number: 002
Approval Date: Dec 23, 1999
Applicant Holder Full Name: MALLINCKRODT HOSP PRODUCTS IP LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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