ANDA 078572

DR REDDYS LABS LTD

FDA Drug Application

Application #078572

Documents

• Letter: 2010-03-25

Application Sponsors

ANDA 078572

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, DELAYED REL PELLETS;ORAL

EQ 90MG BASE

0

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-03-22
LABELING; Labeling	SUPPL	2	AP	2011-11-22
LABELING; Labeling	SUPPL	3	AP	2012-02-28
LABELING; Labeling	SUPPL	4	AP	2014-11-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-11-03	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-11-03	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-09-01	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-09-01	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-09-01	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-09-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	11	Null	7

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78572
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 90MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 90MG BASE","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)