ANDA 075094

CONTRACT PHARMACAL

FDA Drug Application

Application #075094

Documents

• Letter: 2004-06-14

Application Sponsors

ANDA 075094

CONTRACT PHARMACAL

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 75MG BASE

0

RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1999-06-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-09-21

Submissions Property Types

SUPPL	1	Null	0
SUPPL	9	Null	0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75094
            [companyName] => CONTRACT PHARMACAL
            [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
        )

)