NDA 206255

GALDERMA LABS LP

FDA Drug Application

Application #206255

Documents

• Letter: 2014-12-24
• Review: 2016-03-23
• Summary Review: 2016-03-23
• Label: 2015-01-08
• Label: 2018-04-20
• Letter: 2018-04-23
• Letter: 2022-10-17
• Letter: 2022-10-17
• Label: 2022-10-17
• Label: 2022-10-17

Application Sponsors

NDA 206255

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

1

SOOLANTRA

IVERMECTIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2014-12-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2018-04-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-10-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-10-14	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	4	Null	6
SUPPL	5	Null	6
SUPPL	9	Null	7

TE Codes

001

Prescription

AB

CDER Filings

GALDERMA LABS LP

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(
    [0] => Array
        (
            [ApplNo] => 206255
            [companyName] => GALDERMA LABS LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOOLANTRA","activeIngredients":"IVERMECTIN","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/14\/2022","submission":"SUPPL-9","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/206255s005s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/14\/2022","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/206255s005s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206255s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/206255lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/19\/2014","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\\\/2014\\\/206255lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/206255Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206255Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/206255Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/14\/2022","submission":"SUPPL-9","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/206255s005s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/206255Orig1s005,s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/14\/2022","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/206255s005s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/206255Orig1s005,s009ltr.pdf\"}]","notes":">"},{"actionDate":"04\/19\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206255s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206255Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-10-14
        )

)