ANDA 074069

AMNEAL PHARMS LLC

FDA Drug Application

Application #074069

Application Sponsors

ANDA 074069

AMNEAL PHARMS LLC

Marketing Status

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

Application Products

001	TABLET;ORAL	50MG	0	AZATHIOPRINE	AZATHIOPRINE
002	TABLET;ORAL	75MG	0	AZATHIOPRINE	AZATHIOPRINE
003	TABLET;ORAL	100MG	0	AZATHIOPRINE	AZATHIOPRINE

FDA Submissions

	ORIG	1	AP	1996-02-16
LABELING; Labeling	SUPPL	3	AP	2007-02-01
LABELING; Labeling	SUPPL	4	AP	2008-10-23
LABELING; Labeling	SUPPL	6	AP	2011-06-21
LABELING; Labeling	SUPPL	10	AP	2015-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2017-05-25	UNKNOWN
LABELING; Labeling	SUPPL	14	AP	2019-04-23	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	6	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	14	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74069
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZATHIOPRINE","activeIngredients":"AZATHIOPRINE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZATHIOPRINE","submission":"AZATHIOPRINE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)