NDA 212379

FOAMIX

FDA Drug Application

Application #212379

Documents

• Label: 2019-10-21
• Letter: 2019-10-22
• Review: 2020-04-09
• Label: 2021-02-01
• Letter: 2021-02-01
• Letter: 2022-02-24
• Label: 2022-03-03

Application Sponsors

NDA 212379

FOAMIX

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

EQ 4% BASE

1

AMZEEQ

MINOCYCLINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2019-10-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-01-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2022-01-13	N/A

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	6

CDER Filings

FOAMIX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212379
            [companyName] => FOAMIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMZEEQ","activeIngredients":"MINOCYCLINE HYDROCHLORIDE","strength":"EQ 4% BASE","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/18\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212379s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/18\/2019","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\\\/2019\\\/212379s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212379Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212379Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-10-18
        )

)