ANDA 091670

MAYNE PHARMA INC

FDA Drug Application

Application #091670

Application Sponsors

ANDA 091670

MAYNE PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

325MG;4.8355MG

0

OXYCODONE AND ASPIRIN

ASPIRIN; OXYCODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-03-16
REMS; REMS	SUPPL	2	AP	2018-09-18
LABELING; Labeling	SUPPL	4	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-10-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-02-26	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7

TE Codes

001

Prescription

AA

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91670
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE AND ASPIRIN","activeIngredients":"ASPIRIN; OXYCODONE HYDROCHLORIDE","strength":"325MG;4.8355MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCODONE AND ASPIRIN","submission":"ASPIRIN; OXYCODONE HYDROCHLORIDE","actionType":"325MG;4.8355MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)