ANDA 076705

DR REDDYS LABS INC

FDA Drug Application

Application #076705

Application Sponsors

ANDA 076705

DR REDDYS LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 150MG BASE	0	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 300MG BASE	0	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-07-27
LABELING; Labeling	SUPPL	2	AP	2009-05-28
LABELING; Labeling	SUPPL	3	AP	2009-12-28

Submissions Property Types

SUPPL

3

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76705
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 300MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)