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Details for New Drug Application (NDA): 020845

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NDA 020845 describes INOMAX, which is a drug marketed by Mallinckrodt Hosp and is included in one NDA. It is available from one supplier. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INOMAX profile page.

The generic ingredient in INOMAX is nitric oxide. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nitric oxide profile page.

Summary for NDA: 020845

Tradename:
INOMAX
Applicant:
Mallinckrodt Hosp
Ingredient:
nitric oxide
Patents:17
Formulation / Manufacturing:see details

Pharmacology for NDA: 020845

Physiological EffectVasodilation

Suppliers and Packaging for NDA: 020845

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INOMAX
nitric oxide
GAS;INHALATION 020845 NDA INO Therapeutics 64693-002 64693-002-01 1 CYLINDER in 1 CARTON (64693-002-01) > 353 L in 1 CYLINDER
INOMAX
nitric oxide
GAS;INHALATION 020845 NDA INO Therapeutics 64693-002 64693-002-02 1 CYLINDER in 1 CARTON (64693-002-02) > 1963 L in 1 CYLINDER

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:GAS;INHALATIONStrength100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 23, 1999TE:RLD:No
Patent:5,732,693*PEDPatent Expiration:Jun 13, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:5,752,504*PEDPatent Expiration:Jun 13, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,125,846*PEDPatent Expiration:Nov 16, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020845

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 19995,485,827*PED► subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 19995,558,083*PED► subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 19995,485,827*PED► subscribe
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