ANDA 079089

ZYDUS PHARMS USA INC

FDA Drug Application

Application #079089

Documents

• Letter: 2009-07-09
• Label: 2009-07-23

Application Sponsors

ANDA 079089

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

BICALUTAMIDE

BICALUTAMIDE

FDA Submissions

	ORIG	1	AP	2009-07-06
LABELING; Labeling	SUPPL	2	AP	2012-06-21
LABELING; Labeling	SUPPL	3	AP	2012-07-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-04-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-04-16	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	8
SUPPL	4	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79089
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BICALUTAMIDE","activeIngredients":"BICALUTAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/06\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/079089s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BICALUTAMIDE","submission":"BICALUTAMIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-07-06
        )

)