ANDA 065194

EPIC PHARMA LLC

FDA Drug Application

Application #065194

Application Sponsors

ANDA 065194

EPIC PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 150MG BASE	0	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 300MG BASE	0	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-03-22
LABELING; Labeling	SUPPL	2	AP	2006-05-10
LABELING; Labeling	SUPPL	4	AP	2012-02-10
LABELING; Labeling	SUPPL	5	AP	2019-08-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-08-19	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-08-19	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-08-19	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-08-19	STANDARD

Submissions Property Types

SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65194
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLINDAMYCIN HYDROCHLORIDE","submission":"CLINDAMYCIN HYDROCHLORIDE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CLINDAMYCIN HYDROCHLORIDE","submission":"CLINDAMYCIN HYDROCHLORIDE","actionType":"EQ 300MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)