ANDA 090346

EPIC PHARMA LLC

FDA Drug Application

Application #090346

Application Sponsors

ANDA 090346

EPIC PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

BENZPHETAMINE HYDROCHLORIDE

BENZPHETAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2015-12-15
LABELING; Labeling	SUPPL	2	AP	2021-01-06	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15

TE Codes

001

Prescription

AA

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90346
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZPHETAMINE HYDROCHLORIDE","activeIngredients":"BENZPHETAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENZPHETAMINE HYDROCHLORIDE","submission":"BENZPHETAMINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)