ANDA 202220

EPIC PHARMA LLC

FDA Drug Application

Application #202220

Application Sponsors

ANDA 202220

EPIC PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	PROTRIPTYLINE HYDROCHLORIDE	PROTRIPTYLINE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	PROTRIPTYLINE HYDROCHLORIDE	PROTRIPTYLINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2012-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2020-08-11

Submissions Property Types

ORIG	1	Null	17
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202220
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROTRIPTYLINE HYDROCHLORIDE","activeIngredients":"PROTRIPTYLINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROTRIPTYLINE HYDROCHLORIDE","activeIngredients":"PROTRIPTYLINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/19\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/17\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2014-07-17
        )

)