NDA 210361

DERMIRA INC

FDA Drug Application

Application #210361

Documents

• Label: 2018-07-05
• Letter: 2018-07-24
• Review: 2018-11-20
• Pediatric Other: 1900-01-01
• Letter: 2022-04-04
• Label: 2022-04-05
• Letter: 2022-10-31
• Label: 2022-11-01

Application Sponsors

NDA 210361

DERMIRA INC

Marketing Status

• Prescription: 001

Application Products

001

CLOTH;TOPICAL

EQ 2.4% BASE

1

QBREXZA

GLYCOPYRRONIUM TOSYLATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2018-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2020-07-20	N/A
LABELING; Labeling	SUPPL	5	AP	2022-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	15

CDER Filings

DERMIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210361
            [companyName] => DERMIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"QBREXZA","activeIngredients":"GLYCOPYRRONIUM TOSYLATE","strength":"EQ 2.4% BASE","dosageForm":"CLOTH;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/28\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210361lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210361lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210361Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210361Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-06-28
        )

)