NDA 022408

PARAPRO LLC

FDA Drug Application

Application #022408

Documents

• Letter: 2015-01-07
• Label: 2011-01-19
• Summary Review: 2011-02-17
• Letter: 2011-01-20
• Label: 2015-01-05
• Review: 2011-02-16
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Letter: 2021-04-30
• Label: 2021-05-03
• Pediatric Other: 1900-01-01

Application Sponsors

NDA 022408

PARAPRO LLC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;TOPICAL

0.9%

1

NATROBA

SPINOSAD

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2011-01-18	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2014-12-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-04-28	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	6
SUPPL	8	Null	6
SUPPL	10	Null	7

CDER Filings

PARAPRO LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22408
            [companyName] => PARAPRO LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NATROBA","activeIngredients":"SPINOSAD","strength":"0.9%","dosageForm":"SUSPENSION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/30\/2014","submission":"SUPPL-5","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022408s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022408lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NATROBA","submission":"SPINOSAD","actionType":"0.9%","submissionClassification":"SUSPENSION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-12-30
        )

)