ANDA 078921

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078921

Documents

• Letter: 2010-06-30

Application Sponsors

ANDA 078921

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1MG

0

ANASTROZOLE

ANASTROZOLE

FDA Submissions

	ORIG	1	AP	2010-06-28
LABELING; Labeling	SUPPL	3	AP	2015-08-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-08-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-09-05	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	8	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78921
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANASTROZOLE","activeIngredients":"ANASTROZOLE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ANASTROZOLE","submission":"ANASTROZOLE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)