ANDA 208206

AMNEAL PHARMS

FDA Drug Application

Application #208206

Application Sponsors

ANDA 208206

AMNEAL PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

60MG

0

RALOXIFENE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-04-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-08-23	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-10-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	10	Null	7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208206
            [companyName] => AMNEAL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RALOXIFENE HYDROCHLORIDE","activeIngredients":"RALOXIFENE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/08\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/23\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-23
        )

)