ANDA 215398

AMNEAL PHARMS LLC

FDA Drug Application

Application #215398

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 215398

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

1%

0

BEXAROTENE

BEXAROTENE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-27

UNKNOWN

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215398
            [companyName] => AMNEAL PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BEXAROTENE","activeIngredients":"BEXAROTENE","strength":"1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-27
        )

)