ANDA 207141

PRAXAIR DISTRIBUTION

FDA Drug Application

Application #207141

Documents

• Letter: 2018-10-15

Application Sponsors

ANDA 207141

PRAXAIR DISTRIBUTION

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	GAS;INHALATION	100PPM	0	NOXIVENT	NITRIC OXIDE
002	GAS;INHALATION	800PPM	0	NOXIVENT	NITRIC OXIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

002

Prescription

AA

CDER Filings

LINDE GAS EQUIP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207141
            [companyName] => LINDE GAS EQUIP
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOXIVENT","activeIngredients":"NITRIC OXIDE","strength":"100PPM","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NOXIVENT","activeIngredients":"NITRIC OXIDE","strength":"800PPM","dosageForm":"GAS;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/02\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207141Orig1s000Ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-02
        )

)