ANDA 075132

SUN PHARM INDS LTD

FDA Drug Application

Application #075132

Documents

• Letter: 2000-01-14

Application Sponsors

ANDA 075132

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 75MG BASE

0

RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2000-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-06-29
LABELING; Labeling	SUPPL	5	AP	2000-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-11-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-11-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-11-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-05-20
LABELING; Labeling	SUPPL	11	AP	2003-05-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-10-03
LABELING; Labeling	SUPPL	20	AP	2008-02-29

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75132
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)