ANDA 090780

ANCHEN PHARMS

FDA Drug Application

Application #090780

Documents

• Letter: 2015-10-30
• Label: 2015-11-04

Application Sponsors

ANDA 090780

ANCHEN PHARMS

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

ORIG

1

AP

2015-10-28

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90780
            [companyName] => ANCHEN PHARMS
            [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] => [{"actionDate":"10\/28\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/090780s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DULOXETINE HYDROCHLORIDE","submission":"DULOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DULOXETINE HYDROCHLORIDE","submission":"DULOXETINE HYDROCHLORIDE","actionType":"EQ 30MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DULOXETINE HYDROCHLORIDE","submission":"DULOXETINE HYDROCHLORIDE","actionType":"EQ 60MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2015-10-28
        )

)