ANDA 040446

SUN PHARM INDS INC

FDA Drug Application

Application #040446

Documents

• Letter: 2003-04-09

Application Sponsors

ANDA 040446

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	50MG	0	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE
002	TABLET;ORAL	100MG	0	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-08-08
LABELING; Labeling	SUPPL	7	AP	2009-06-23
REMS; REMS	SUPPL	11	AP	2018-09-18

Submissions Property Types

SUPPL

11

Null

15

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40446
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEPERIDINE HYDROCHLORIDE","activeIngredients":"MEPERIDINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MEPERIDINE HYDROCHLORIDE","activeIngredients":"MEPERIDINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEPERIDINE HYDROCHLORIDE","submission":"MEPERIDINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MEPERIDINE HYDROCHLORIDE","submission":"MEPERIDINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)