ANDA 077621

ZYDUS PHARMS USA

FDA Drug Application

Application #077621

Application Sponsors

ANDA 077621

ZYDUS PHARMS USA

Marketing Status

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

Application Products

001	TABLET;ORAL	50MG	0	AZATHIOPRINE	AZATHIOPRINE
002	TABLET;ORAL	25MG	0	AZATHIOPRINE	AZATHIOPRINE
003	TABLET;ORAL	75MG	0	AZATHIOPRINE	AZATHIOPRINE
004	TABLET;ORAL	100MG	0	AZATHIOPRINE	AZATHIOPRINE

FDA Submissions

	ORIG	1	AP	2007-03-15
LABELING; Labeling	SUPPL	2	AP	2008-09-05
LABELING; Labeling	SUPPL	4	AP	2009-02-17
LABELING; Labeling	SUPPL	5	AP	2011-06-20
LABELING; Labeling	SUPPL	8	AP	2015-07-20	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-04-23	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	8	Null	7
SUPPL	13	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77621
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZATHIOPRINE","activeIngredients":"AZATHIOPRINE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AZATHIOPRINE","activeIngredients":"AZATHIOPRINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AZATHIOPRINE","activeIngredients":"AZATHIOPRINE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AZATHIOPRINE","activeIngredients":"AZATHIOPRINE","strength":"100MG","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"},{"actionDate":"AZATHIOPRINE","submission":"AZATHIOPRINE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AZATHIOPRINE","submission":"AZATHIOPRINE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AZATHIOPRINE","submission":"AZATHIOPRINE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)