ANDA 040881

MIKART

FDA Drug Application

Application #040881

Application Sponsors

ANDA 040881

MIKART

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

300MG/15ML;10MG/15ML

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	2010-02-25
LABELING; Labeling	SUPPL	2	AP	2011-06-24
LABELING; Labeling	SUPPL	3	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-12-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-12-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2018-08-24	STANDARD
REMS; REMS	SUPPL	10	AP	2018-09-18
LABELING; Labeling	SUPPL	11	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-10-11	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7

TE Codes

001

Prescription

AA

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40881
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"300MG\/15ML;10MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"300MG\/15ML;10MG\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)