ANDA 090118

SUN PHARM INDS INC

FDA Drug Application

Application #090118

Application Sponsors

ANDA 090118

SUN PHARM INDS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	325MG;5MG	0	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE
002	TABLET;ORAL	325MG;7.5MG	0	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE
003	TABLET;ORAL	325MG;10MG	0	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	2008-12-23
LABELING; Labeling	SUPPL	2	AP	2011-06-27
LABELING; Labeling	SUPPL	13	AP	2013-10-25	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-12-15	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-12-15	STANDARD
LABELING; Labeling	SUPPL	22	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	23	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	24	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	27	AP	2018-09-18
LABELING; Labeling	SUPPL	29	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	32	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	33	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	16	Null	15
SUPPL	22	Null	7
SUPPL	23	Null	15
SUPPL	24	Null	15
SUPPL	27	Null	7
SUPPL	29	Null	7
SUPPL	32	Null	15
SUPPL	33	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA
003	Prescription	AA

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90118
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"325MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"325MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"325MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)