ANDA 077184

SUN PHARM INDS INC

FDA Drug Application

Application #077184

Application Sponsors

ANDA 077184

SUN PHARM INDS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

325MG;37.5MG

0

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2011-08-02
LABELING; Labeling	SUPPL	6	AP	2010-09-13
LABELING; Labeling	SUPPL	8	AP	2011-08-22
LABELING; Labeling	SUPPL	11	AP	2014-07-11	STANDARD
LABELING; Labeling	SUPPL	12	AP	2016-06-24	STANDARD
LABELING; Labeling	SUPPL	13	AP	2017-06-29	STANDARD
REMS; REMS	SUPPL	15	AP	2018-09-18

Submissions Property Types

SUPPL	5	Null	7
SUPPL	8	Null	15
SUPPL	11	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	15	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77184
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","strength":"325MG;37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","actionType":"325MG;37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)