NDA 210566

MAYNE PHARMA

FDA Drug Application

Application #210566

Documents

• Label: 2018-05-24
• Letter: 2018-05-29
• Review: 2018-11-20
• Label: 2019-04-24
• Label: 2020-04-24
• Letter: 2020-04-24
• Letter: 2021-08-19
• Label: 2021-08-19
• Letter: 2022-07-20
• Label: 2022-07-20

Application Sponsors

NDA 210566

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

0.05%

1

LEXETTE

HALOBETASOL PROPIONATE

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination	ORIG	1	AP	2018-05-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-04-23	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2021-08-18	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2022-07-19	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	6
SUPPL	3	Null	15
SUPPL	5	Null	15

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210566
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEXETTE","activeIngredients":"HALOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/23\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210566s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210566s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210566s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210566s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210566s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210566s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210566Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210566Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/23\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210566s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210566Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"04\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/210566s001lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2020-04-23
        )

)