ANDA 079020

SUN PHARMA GLOBAL

FDA Drug Application

Application #079020

Application Sponsors

ANDA 079020

SUN PHARMA GLOBAL

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 006
• None (Tentative Approval): 007

Application Products

001	CAPSULE; ORAL	10MG	0	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE
002	CAPSULE; ORAL	18MG	0	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE
003	CAPSULE; ORAL	25MG	0	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE
004	CAPSULE; ORAL	40MG	0	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE
005	CAPSULE; ORAL	60MG	0	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE
006	CAPSULE; ORAL	80MG	0	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE
007	CAPSULE; ORAL	100MG	0	ATOMOXETINE HYDROCHLORIDE	ATOMOXETINE HYDROCHLORIDE

FDA Submissions

ORIG

1

TA

2012-05-11

Submissions Property Types

ORIG

1

Null

7

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79020
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"18MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"40MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"60MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"80MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"18MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"80MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"CAPSULE; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)