ANDA 065447

EPIC PHARMA LLC

FDA Drug Application

Application #065447

Documents

• Letter: 2015-08-21

Application Sponsors

ANDA 065447

EPIC PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	150MG	0	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE
002	TABLET;ORAL	300MG	0	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2015-08-18

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65447
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEMECLOCYCLINE HYDROCHLORIDE","activeIngredients":"DEMECLOCYCLINE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEMECLOCYCLINE HYDROCHLORIDE","activeIngredients":"DEMECLOCYCLINE HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEMECLOCYCLINE HYDROCHLORIDE","submission":"DEMECLOCYCLINE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEMECLOCYCLINE HYDROCHLORIDE","submission":"DEMECLOCYCLINE HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)