ANDA 090453

EPIC PHARMA LLC

FDA Drug Application

Application #090453

Application Sponsors

ANDA 090453

EPIC PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	5MG	0	MOLINDONE HYDROCHLORIDE	MOLINDONE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	MOLINDONE HYDROCHLORIDE	MOLINDONE HYDROCHLORIDE
003	TABLET;ORAL	25MG	0	MOLINDONE HYDROCHLORIDE	MOLINDONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2015-03-20
LABELING; Labeling	SUPPL	4	AP	2017-02-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90453
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOLINDONE HYDROCHLORIDE","activeIngredients":"MOLINDONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MOLINDONE HYDROCHLORIDE","activeIngredients":"MOLINDONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MOLINDONE HYDROCHLORIDE","activeIngredients":"MOLINDONE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MOLINDONE HYDROCHLORIDE","submission":"MOLINDONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MOLINDONE HYDROCHLORIDE","submission":"MOLINDONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MOLINDONE HYDROCHLORIDE","submission":"MOLINDONE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)