ANDA 200886

MAYNE PHARMA

FDA Drug Application

Application #200886

Application Sponsors

ANDA 200886

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

10MG

0

METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2018-02-26
LABELING; Labeling	SUPPL	2	AP	2022-09-14	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-09-14	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-09-14	STANDARD

Submissions Property Types

ORIG	1	Null	29
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AB1

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200886
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)