ANDA 204815

MACLEODS PHARMS LTD

FDA Drug Application

Application #204815

Application Sponsors

ANDA 204815

MACLEODS PHARMS LTD

Marketing Status

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

Application Products

001	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 20MG BASE	0	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE
002	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 30MG BASE	0	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE
003	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 60MG BASE	0	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-03-23

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204815
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DULOXETINE HYDROCHLORIDE","activeIngredients":"DULOXETINE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-23
        )

)