ANDA 090609

DR REDDYS LABS LTD

FDA Drug Application

Application #090609

Application Sponsors

ANDA 090609

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 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	AP	2018-02-23
LABELING; Labeling	SUPPL	5	AP	2022-05-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	31

TE Codes

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

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90609
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATOMOXETINE HYDROCHLORIDE","activeIngredients":"ATOMOXETINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"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
        )

)