NDA 214902

SOL-GEL TECHNOLOGIES LTD

FDA Drug Application

Application #214902

Documents

• Label: 2021-07-27
• Letter: 2021-07-27
• Review: 2022-07-20

Application Sponsors

NDA 214902

SOL-GEL TECHNOLOGIES LTD

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.1%;3%

0

TWYNEO

TRETINOIN;BENZOYL PEROXIDE

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

AP

2021-07-26

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SOL-GEL TECHNOLOGIES LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214902
            [companyName] => SOL-GEL TECHNOLOGIES LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TWYNEO","activeIngredients":"TRETINOIN;BENZOYL PEROXIDE","strength":"0.1%;3%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/26\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214902s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214902s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214902Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-07-26
        )

)