ANDA 076990

SUN PHARM INDS LTD

FDA Drug Application

Application #076990

Documents

• Other Important Information from FDA: 2005-08-01

Application Sponsors

ANDA 076990

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

EQ 40MG BASE

0

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-12-13
LABELING; Labeling	SUPPL	2	AP	2005-08-09
LABELING; Labeling	SUPPL	5	AP	2006-10-05
LABELING; Labeling	SUPPL	6	AP	2007-10-10
LABELING; Labeling	SUPPL	7	AP	2008-07-07
LABELING; Labeling	SUPPL	8	AP	2008-10-17
LABELING; Labeling	SUPPL	9	AP	2008-10-17
LABELING; Labeling	SUPPL	11	AP	2009-07-09
LABELING; Labeling	SUPPL	12	AP	2010-03-17
LABELING; Labeling	SUPPL	13	AP	2010-08-30
LABELING; Labeling	SUPPL	14	AP	2012-02-28
LABELING; Labeling	SUPPL	16	AP	2014-12-05	STANDARD
LABELING; Labeling	SUPPL	18	AP	2014-12-05	STANDARD
LABELING; Labeling	SUPPL	19	AP	2014-12-05	STANDARD
LABELING; Labeling	SUPPL	20	AP	2014-12-05	STANDARD
LABELING; Labeling	SUPPL	21	AP	2015-10-23	STANDARD
LABELING; Labeling	SUPPL	22	AP	2021-06-07	STANDARD
LABELING; Labeling	SUPPL	23	AP	2021-06-07	STANDARD
LABELING; Labeling	SUPPL	26	AP	2021-06-07	STANDARD
LABELING; Labeling	SUPPL	28	AP	2021-06-07	STANDARD

Submissions Property Types

SUPPL	12	Null	7
SUPPL	14	Null	15
SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	7
SUPPL	21	Null	7
SUPPL	22	Null	15
SUPPL	23	Null	15
SUPPL	26	Null	7
SUPPL	28	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76990
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)