ANDA 079017

ZYDUS PHARMS USA INC

FDA Drug Application

Application #079017

Application Sponsors

ANDA 079017

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2010-09-16
LABELING; Labeling	SUPPL	2	AP	2013-08-07
LABELING; Labeling	SUPPL	5	AP	2015-08-25	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-08-25	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79017
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"18MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"60MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"80MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"18MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"80MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATOMOXETINE HYDROCHLORIDE","submission":"ATOMOXETINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)