NDA 022368

PHARMAXIS LTD

FDA Drug Application

Application #022368

Documents

• Letter: 2010-10-12
• Review: 2011-05-19
• Label: 2010-10-13
• Summary Review: 2011-05-19
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2021-08-16
• Label: 2021-08-17

Application Sponsors

NDA 022368

PHARMAXIS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	POWDER;INHALATION	N/A,5MG,10MG,20MG,40MG	1	ARIDOL KIT	MANNITOL
002	POWDER; INHALATION	10MG	2	ARIDOL	MANNITOL
003	POWDER; INHALATION	20MG	2	ARIDOL	MANNITOL
004	POWDER; INHALATION	40MG	2	ARIDOL	MANNITOL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2010-10-05	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-08-13	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	3	Null	7

CDER Filings

PHARMAXIS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22368
            [companyName] => PHARMAXIS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARIDOL","activeIngredients":"MANNITOL","strength":"10MG","dosageForm":"POWDER; INHALATION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"ARIDOL","activeIngredients":"MANNITOL","strength":"20MG","dosageForm":"POWDER; INHALATION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"ARIDOL","activeIngredients":"MANNITOL","strength":"40MG","dosageForm":"POWDER; INHALATION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"ARIDOL KIT","activeIngredients":"MANNITOL","strength":"N\/A,5MG,10MG,20MG,40MG","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/05\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022368S000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ARIDOL","submission":"MANNITOL","actionType":"10MG","submissionClassification":"POWDER; INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">TBD"},{"actionDate":"ARIDOL","submission":"MANNITOL","actionType":"20MG","submissionClassification":"POWDER; INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">TBD"},{"actionDate":"ARIDOL","submission":"MANNITOL","actionType":"40MG","submissionClassification":"POWDER; INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">TBD"},{"actionDate":"ARIDOL KIT","submission":"MANNITOL","actionType":"N\/A,5MG,10MG,20MG,40MG","submissionClassification":"POWDER;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2010-10-05
        )

)