ANDA 040736

AMNEAL PHARMS NY

FDA Drug Application

Application #040736

Application Sponsors

ANDA 040736

AMNEAL PHARMS NY

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

325MG;5MG

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	2006-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2013-04-26
LABELING; Labeling	SUPPL	10	AP	2011-06-24
LABELING; Labeling	SUPPL	12	AP	2014-04-04	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-01-05	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-12-16	STANDARD
REMS; REMS	SUPPL	18	AP	2018-09-18
LABELING; Labeling	SUPPL	19	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	21	AP	2019-10-10	STANDARD
LABELING; Labeling	SUPPL	28	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	8	Null	19
SUPPL	10	Null	7
SUPPL	12	Null	15
SUPPL	14	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	21	Null	7
SUPPL	28	Null	7

TE Codes

001

Prescription

AA

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40736
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"325MG;5MG","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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)