ANDA 209861

ANI PHARMS INC

FDA Drug Application

Application #209861

Application Sponsors

ANDA 209861

ANI PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

75MG

0

BEXAROTENE

BEXAROTENE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-05-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-11-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209861
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BEXAROTENE","activeIngredients":"BEXAROTENE","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/08\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/23\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-11-23
        )

)