ANDA 076900

ZYDUS PHARMS USA

FDA Drug Application

Application #076900

Application Sponsors

ANDA 076900

ZYDUS PHARMS USA

Marketing Status

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

Application Products

001	TABLET;ORAL	25MG	0	ATENOLOL	ATENOLOL
002	TABLET;ORAL	50MG	0	ATENOLOL	ATENOLOL
003	TABLET;ORAL	100MG	0	ATENOLOL	ATENOLOL

FDA Submissions

	ORIG	1	AP	2005-01-28
LABELING; Labeling	SUPPL	2	AP	2006-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2007-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2007-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2007-03-01
LABELING; Labeling	SUPPL	9	AP	2009-02-19
LABELING; Labeling	SUPPL	11	AP	2009-02-19
LABELING; Labeling	SUPPL	12	AP	2009-02-19
LABELING; Labeling	SUPPL	17	AP	2008-08-29
LABELING; Labeling	SUPPL	18	AP	2009-01-14
LABELING; Labeling	SUPPL	23	AP	2011-09-13
LABELING; Labeling	SUPPL	24	AP	2014-10-31	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	23	Null	15
SUPPL	24	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76900
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)