ANDA 090377

IMPAX LABS

FDA Drug Application

Application #090377

Documents

• Letter: 2010-03-04

Application Sponsors

ANDA 090377

IMPAX LABS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.4MG

0

TAMSULOSIN HYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-03-02
LABELING; Labeling	SUPPL	3	AP	2011-10-31

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90377
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAMSULOSIN HYDROCHLORIDE","activeIngredients":"TAMSULOSIN HYDROCHLORIDE","strength":"0.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TAMSULOSIN HYDROCHLORIDE","submission":"TAMSULOSIN HYDROCHLORIDE","actionType":"0.4MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)