ANDA 090635

THEPHARMANETWORK LLC

FDA Drug Application

Application #090635

Documents

• Other: 2015-06-30

Application Sponsors

ANDA 090635

THEPHARMANETWORK LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	10MG	0	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE
002	TABLET;ORAL	5MG	0	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-11-25
LABELING; Labeling	SUPPL	3	AP	2012-07-09
LABELING; Labeling	SUPPL	4	AP	2012-07-09
REMS; REMS	SUPPL	5	AP	2013-04-15
LABELING; Labeling	SUPPL	7	AP	2014-07-23	STANDARD
REMS; REMS	SUPPL	9	AP	2014-08-19
REMS; REMS	SUPPL	10	AP	2015-06-26
LABELING; Labeling	SUPPL	11	AP	2015-06-04	STANDARD
REMS; REMS	SUPPL	13	AP	2016-04-20
REMS; REMS	SUPPL	14	AP	2016-09-30
REMS; REMS	SUPPL	16	AP	2017-05-26
LABELING; Labeling	SUPPL	19	AP	2019-07-16	STANDARD
REMS; REMS	SUPPL	20	AP	2018-09-18
LABELING; Labeling	SUPPL	21	AP	2019-07-16	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-07-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	7	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	7
SUPPL	16	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	7
SUPPL	22	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

THEPHARMANETWORK LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90635
            [companyName] => THEPHARMANETWORK LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHADONE HYDROCHLORIDE","submission":"METHADONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)