ANDA 078900

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078900

Application Sponsors

ANDA 078900

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

FINASTERIDE

FINASTERIDE

FDA Submissions

	ORIG	1	AP	2009-12-28
LABELING; Labeling	SUPPL	2	AP	2012-05-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78900
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINASTERIDE","activeIngredients":"FINASTERIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FINASTERIDE","submission":"FINASTERIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)