ANDA 040608

MIKART

FDA Drug Application

Application #040608

Application Sponsors

ANDA 040608

MIKART

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	300MG;2.5MG	0	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
002	TABLET;ORAL	300MG;5MG	0	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
003	TABLET;ORAL	300MG;7.5MG	0	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
004	TABLET;ORAL	300MG;10MG	0	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-12-30
LABELING; Labeling	SUPPL	7	AP	2011-07-01
LABELING; Labeling	SUPPL	8	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	2018-08-24	STANDARD
REMS; REMS	SUPPL	13	AP	2018-09-18
LABELING; Labeling	SUPPL	14	AP	2018-09-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-10-08	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-03-04	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	15

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40608
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"300MG;2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"300MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"300MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"},{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"300MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"300MG;2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"300MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"300MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"300MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)