ANDA 215433

COSETTE

FDA Drug Application

Application #215433

Documents

• Letter: 2022-11-28

Application Sponsors

ANDA 215433

COSETTE

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.05%

0

TAZAROTENE

TAZAROTENE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

COSETTE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215433
            [companyName] => COSETTE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAZAROTENE","activeIngredients":"TAZAROTENE","strength":"0.05%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-13
        )

)